Engineering Jobs in Durham Durham County, NC

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer

About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.

Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

Supervisory Responsibilities: 

·      None 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 Salary Range:

$190,000-210,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

Title: QA Data Steward

Duration: 12 month contract, possibility of extension

Location: Durham, NC

Position Description

The QA Data Steward (Contractor) supports the QA-for-QC organization by performing quality-

related activities and Computer System Validation (CSV) tasks for QC laboratory computer systems.

This role is responsible for supporting QA computer systems used by QC laboratories, including

Darwin and future-state LabVantage LIMS, to ensure systems remain compliant, validated, and

operationally effective.

The contractor performs defined quality system activities related to computerized systems, including

CSV execution, master data management, and support of system-related investigations and

remediation activities. This role requires strong understanding of GMP, data integrity principles, CSV

expectations, and QC laboratory workflows. While the contractor performs quality and CSV activities,

final quality decision-making authority remains with QA leadership unless otherwise designated.

Key Objectives/Deliverables

CSV / QA Computer System Support

• Perform CSV activities for QC laboratory systems, including execution of validation test

scripts, data verification, and evidence generation.

• Support lifecycle management of QA computer systems used by QC, including system

changes, upgrades, and periodic review activities.

• Support quality system activities related to computerized systems, including minor

investigations, discrepancy documentation, and remediation support.

• Support inspection readiness for QC systems by preparing validation and system evidence

packages.

LIMS (Darwin / LabVantage)

• Create, revise, and maintain LIMS master data (specifications, methods, materials,

instruments, workflows, user configurations).

• Support cross-functional review of documents required for master data setup and system

configuration.

• Troubleshoot master data or configuration issues and support system migration or

implementation activities (e.g., Darwin to LabVantage).

Operational Support

• Collaborate with QC, TS/MS, QA-for-QC, and IT on QC laboratory system activities and

updates.

• Support planning, prioritization, and communication of system and master data activities

impacting QC laboratories.Compliance & Documentation

• Follow GMP, data integrity, and documentation requirements for all activities performed.

• Maintain training compliance and documentation accuracy.

• Provide system and validation data to support audits and inspections.

Requirements (Education, Experience, Training)

• Bachelor’s degree in computer science, engineering, science, or relevant technical field, or

equivalent experience.

• Minimum 3 years of experience supporting GMP computer systems in a pharmaceutical or

medical device environment.

• Experience performing or supporting CSV activities for QC-related systems.

• Basic understanding of QC laboratory processes, analytical testing workflows, and data

integrity principles.

• Strong attention to detail with understanding of electronic records and data structures.

Preferred Attributes (Not Required)

• Experience specifically with Darwin and/or LabVantage LIMS.

• Experience with SAP, TrackWise, Veeva QDocs, LES, or instrument data systems.

• Familiarity with CSV documentation, testing execution, and system remediation activities.

• Strong interpersonal, communication, and technical writing skills.

Senior Director, Process Engineering & Contract Manufacturing Scale-Up

Location: Durham, NC (In-Office) 

Reports To: SVP Operations

Applying

To apply directly to this role, please email a non-ChatGPT paragraph explaining why you believe you would be the best fit for this role and attach your resume as a PDF. Applying via email is the only way to be considered.

About Carpe

Carpe is the fastest-growing deodorant brand in the United States. Our team is composed of ~25 incredibly smart people working together in person in downtown Durham, NC. Our office is open, collaborative, and high energy.

We build products that solve real problems for millions of people who struggle with excessive sweating. Our growth over the past several years has been rapid, and we are continuing to expand across retail, ecommerce, and new product categories.

As the company scales, building a strong, reliable, and scalable manufacturing foundation is critical to our long-term success.

The Role

We are seeking a high-ownership process engineering leader with a strong chemical engineering background who thrives in fast-growing environments and enjoys building systems that support scale. This is not a procurement or vendor management role. It is a technical manufacturing role focused on process engineering, scale-up, and improving manufacturing performance.

This role exists to build Carpe’s manufacturing process engineering capability as we expand production across multiple product categories and manufacturing partners. The primary focus is on developing robust, scalable processes that consistently deliver product performance.

This is a hands-on technical role. You will work directly with manufacturing teams to define critical process parameters, troubleshoot production challenges, and improve process reliability as we scale.

You will partner closely with Product Development, Operations, and Quality to translate product innovation into well-defined, scalable manufacturing processes. Success in this role requires the ability to develop long-term process engineering frameworks while also working directly with manufacturing teams to solve technical challenges and improve production performance.

What You’ll Do

Process Engineering & Manufacturing Science

• Build and lead Carpe’s internal manufacturing process engineering capability
• Work directly with contract manufacturing teams to document and refine production processes
• Identify and define critical process parameters that drive product consistency and performance
• Lead process characterization work, including DOE design and execution
• Improve process robustness and repeatability across manufacturing partners
• Troubleshoot complex manufacturing challenges and support manufacturing teams in solving production issues
• Drive continuous improvement initiatives across manufacturing operations

Technology Transfer & Product Scale-Up

• Lead the technical transfer of new products from development into commercial manufacturing
• Work directly with contract manufacturers to scale formulations and processes successfully
• Partner closely with Product Development to translate product specifications into scalable manufacturing processes
• Oversee pilot trials, validation runs, and commercialization readiness for new product launches
• Ensure new products are successfully and reliably launched across manufacturing partners

Manufacturing Performance & Continuous Improvement

• Establish operational metrics and performance tracking across contract manufacturing partners
• Improve manufacturing efficiency, yield, and process reliability
• Lead root cause investigations and corrective actions related to manufacturing issues
• Implement stronger process control and operational discipline across manufacturing partners
• Develop scalable manufacturing frameworks that support continued company growth

Cross-Functional Collaboration

• Partner closely with Product Development to ensure manufacturing processes support product performance requirements
• Collaborate with Quality and Regulatory to ensure manufacturing processes meet compliance and quality standards
• Work with supply chain and planning teams to support production scheduling and inventory needs
• Provide manufacturing insight during product development and innovation planning

Contract Manufacturing Leadership

• Own and manage Carpe’s network of contract manufacturing partners
• Build strong working relationships with technical teams at manufacturing partners
• Improve operational performance across quality, delivery, and cost
• Lead onboarding and qualification of new manufacturing partners as capacity expands
• Ensure manufacturing partners are prepared to support both current production and future growth
• Serve as the primary operational leader responsible for manufacturing performance across the network

Who You Are

• Bachelor’s degree in Chemical Engineering, Manufacturing Engineering, or a related technical discipline
• 10–15+ years of experience in manufacturing, process engineering, or operations leadership within consumer packaged goods, personal care, or related industries
• Experience with emulsions, OTC personal care, or topical formulation manufacturing
• Experience managing contract manufacturing networks and external production partners
• Strong technical background in manufacturing processes and scale-up
• Experience working with highly structured emulsions or shear-sensitive formulations
• Demonstrated ability to build systems, processes, and infrastructure in growing organizations
• Comfortable operating in fast-moving environments where both strategy and hands-on execution are required
• Willing and able to travel a lot (and last minute) 
• Strong engineering instincts and problem-solving ability
• Ability to work directly with manufacturing partners to improve processes and solve technical challenges

Bonus If You Have

• Background in manufacturing engineering or process engineering leadership roles
• Experience scaling products across multiple contract manufacturing sites
• Experience building manufacturing infrastructure in high-growth CPG environments

What You’ll Get

• Direct collaboration with senior leadership as we scale the business
• Opportunity to build and own Carpe’s manufacturing infrastructure during a major growth phase
• Competitive compensation based on experience and level
• Health, vision, and dental coverage
• Flexible PTO
• A front-row seat to the growth of one of the most disruptive brands in body care



Applying

To apply directly to this role, please email a non-ChatGPT paragraph explaining why you believe you would be the best fit for this role and attach your resume as a PDF. Applying via email is the only way to be considered.

Work Expectations:

The EIC Technician will:

• Ensure that all electrical equipment is in safe operating condition
• Practice safe work habits daily and ensure all safety processes are followed.
• Maintain proper tools in good working condition and keep work areas clean.
• Maintain mechanical and electrical knowledge via in-going training, industry workshops, and technical reading.
• Assist with developing training documentation and participate in the training of new maintenance team members.

Key Responsibilities:

• Attend daily shift meetings to discuss prioritized work orders and minimizing downtime.
• Perform designated electronic technical duties to ensure system performance.
• Troubleshoot and resolve control systems issues to minimize downtime.
• Support project work with Controls Engineers, from concept to completion.
• Perform emergency repairs and assist in installing new equipment.
• Document work performed on control systems and support process improvements.
• Adhere to safety guidelines and actively participate in safety programs.
• You will work on challenging assignments that include investigating, troubleshooting, and solving a wide variety of instrumentation & controls engineering issues
• Provide direct support for Controls Engineering functions (OT-Operations Technology) in manufacturing processes.
• Perform daily engagement/troubleshooting with end-to-end systems, including machine controls, SCADA, and interfaces with upper-level systems (MES and SAP).
• Conduct equipment installations and system development/troubleshooting as required to align to current standards.
• Investigate connectivity issues to diagnose and resolve network connection problems.
• Assist in maintaining program/PLC backups for devices to ensure data integrity and recovery readiness.
• Provide technical support for troubleshooting Allen-Bradley, Siemens, and other PLC systems.
• Support and troubleshoot Profibus, ControlNet, and Ethernet data communication systems.
• Replace defective components or parts, using hand tools and precision instruments.
• Set up and operate specialized or standard test equipment to diagnose, test, or analyze the performance of electronic components, assemblies, or systems.
• Read blueprints, wiring diagrams, schematic drawings, or engineering instructions for assembling electronics units, applying knowledge of electronic theory and components.
• Identify and resolve equipment malfunctions, working with manufacturers or field representatives as necessary to procure replacement parts.
• Review electrical engineering plans to ensure adherence to design specifications and compliance with applicable electrical codes and standards.
• Assemble, test, or maintain circuitry or electronic components, according to engineering instructions, technical manuals, or knowledge of electronics, using hand or power tools.
• Review existing electrical engineering criteria to identify necessary revisions, deletions, or amendments to outdated material.
• Maintain system logs or manuals to document testing or operation of equipment.
• Educate equipment operators on the proper use of equipment.
• Integrate software or hardware components, using computer, microprocessor, or control architecture.
• Install or maintain electrical control systems, industrial automation systems, or electrical equipment, including control circuits, variable speed drives, or programmable logic controllers.
• Execute PM work orders and create work orders for issues found during PM inspections.
• Troubleshoot, repair, improve, and maintain all equipment including all electrical components, drive systems, conveyors, processing equipment, pneumatic and hydraulic systems, utilities, etc.
• Utilize shop equipment, measurement and other diagnostic tools, and power and hand tools to assess the condition of new and used equipment.
• Maintain and troubleshoot PLC, HMI, and vendor developed programs.
• Become SAP proficient to pull weekly work schedule and evaluate work orders and concerns to escalate appropriately to ensure scheduled work can be completed.
• Prepare maintenance daily reports using activity logs, analysis, and trends.
• Provide electrical support to capital and internal projects. This includes documentation, job scopes, managing contractors, and participating in meetings.
• Any other duties as assigned by management.

Requirements:

Knowledge, Skills, Abilities & Other Characteristics:

• Experience with PLCs and HMIs strongly preferred.
• Advanced understanding of control systems, relays, sensors, fuses, breakers, and computer networks.
• Capable of operating hand, power, and specialized tools
• Excellent problem-solving and communication skills
• Strong computer skills and willingness to use tablets
• Basic understanding of mechanics
• Knowledge of SAP PM preferred

Minimum Education:

• Bachelor’s Degree, College Diploma, or Equivalent experience
• 1 years of production/operational work required
• 1 year of experience in batch, continuous, and discrete manufacturing; work experience related to packaging lines.

PilotCBP Air Interdiction Agent

NEW RECRUITMENT AND RETENTION INCENTIVES!

Air and Marine Operations (AMO), a component of U.S. Customs and Border Protection (CBP), offers skilled Pilots interested in law enforcement an opportunity to work with an elite team of highly trained professionals whose camaraderie, pride, and purpose are hallmarks of their daily mission to protect America.

If you are looking for an exciting and rewarding career with excellent pay, exceptional federal benefits and job stability, now is the time to make your move: become an Air Interdiction Agent. AMO is actively recruiting for these full-time security-based opportunities with a streamlined application process. Notably, seasoned pilots and those with military training are in demandAPPLY TODAY!

DONT FORGET TO CHECK OUT THE INCENTIVES SEE SALARY SECTION BELOW!

Duty Locations

Locations are offered based on operational requirements, mission requirements, and critical agency hiring needs as determined by AMO. You must be willing to work at any duty location within the region you select to include but not limited to the following:

Southeast Region:Homestead, FL and CAMB:Aguadilla, PR

Southwest Region: Tucson and Yuma, AZ; San Diego, CA; El Paso, Laredo, and McAllen, TX

NASOC UAS locations:Sierra Vista, AZ; San Angelo, TX

Duties and Responsibilities

As an Air Interdiction Agent (AIA) you will perform aviation-based law enforcement operations for the detection, prevention, interdiction, and apprehension of terrorists, terrorist weapons, and other contraband and persons from illegally entering or attacking the United States. Typical duties include:

• Conducting air patrol, surveillance, and pursuit activities related to the interdiction of smuggled contraband via land vehicles, aircraft, or vessels.
• Monitoring behavior patterns and activities of suspect persons, vehicles, or vessels believed to be engaged in illegal activities.
• Collecting, refining, and analyzing strategic and tactical intelligence.
• Supporting search and rescue and humanitarian efforts.

Salary and Benefits

Begin your career as an Air Interdiction Agent (AIA) and make up to $85,270 to - $110,846 per year based on your qualifications for the GS-11 grade level and possible extra compensation based on your duty location (see below).

Recruitment Incentive:New hires may be eligible to receive a one-time Recruitment Incentive payout of $10,000 after completing Federal Law Enforcement Training Academy (FLETC) (1 year service agreement will need to be completed) (Recruitment Incentive is only available to new Federal employees as described in 5 CFR 575.102. Eligibility will be determined by Human Resources.)

Your starting salary will include Special Salary Rate (SSR); Law Enforcement Availability Pay (LEAP); Recruitment Incentive; and Retention Incentive.

This career ladder position has a grade level progression of GS-11, GS-12, and GS-13. You may be eligible for a promotion to the next higher grade level automatically (without re-applying) once you complete 52 weeks at each grade level (with supervisor approval).

Example of annual compensation for the first three years at our new-hire locations which are currently authorized to receive LEAP (amounts below include the SSR + LEAP).

• GS-11, 1st year annual pay - $106,588
• GS-12, 2nd year annual pay - $127,754
• GS-13, 3rd year annual pay - $151,918

Example of annual compensation for the first three years at our new-hire locations which are currently authorized to receive a 10% Retention Incentive (amounts below include the SSR + LEAP + 10% Retention Incentive UAS Sites: Sierra Vista, AZ; Grand Forks, ND; San Angelo, TX).

• GS-11, 1st year annual pay - $115,115
• GS-12, 2nd year annual pay - $137,974
• GS-13, 3rd year annual pay - $164,071

Example of annual compensation for the first three years at our new-hire locations which are currently authorized to receive a 25% Recruitment Incentive (amounts below include the SSR + LEAP + 25% Recruitment Incentive CAMB location only; Aguadilla, PR).

• GS-11, 1st year annual pay - $127,906
• GS-12, 2nd year annual pay - $153,305
• GS-13, 3rd year annual pay - $182,302

Retention Incentive: Retention Incentive is contingent on eligibility. Eligibility will be determined by Human Resources.

• RI: Retention Incentive (25% for UAS Sites, Sierra Vista, AZ, Grand Forks, ND, San Angelo, TX)

• RI: Retention Incentive (25% for Key West, FL)

RI: Retention Incentive (25% for Caribbean Air and Marine Branch (CAMB) and subordinate locations)

Air Interdiction Agents are eligible to select from an array of federal employment benefits that include health, dental and other insurance plans, a generous annual and sick leave program, and participation in the Thrift Savings Plan, a retirement plan akin to a traditional and ROTH 401(k) offering.

Qualifications

Experience:You qualify for the GS-11 grade level if you possess one (1) year of specialized professional aviation experience performing duties such as:

• Flying as a Pilot-in-Command or sole manipulator in an airplane and helicopter in all environments of flight, including night, poor weather, unfavorable terrain, low altitudes, or speed.
• Evaluating information rapidly and making judicious decisions promptly during in-flight operations.
• Developing strategies and coordinating aircraft and ground assets.
• Using information systems and databases to conduct information surveys, queries, update files and disseminate information.
• Experience may include Operation of an aircraft as Captain, Pilot in Command, Aircraft Commander, First Officer, Certified Flight Instructor, Second in Command, or Co-pilot.

Hiring Minimums:

Certification & Ratings: A current FAA Commercial or ATP Pilot Certification with one of the following ratings:

• Dual Rated: Airplane (Single-engine land or multi-engine land) with instrument rating AND Rotorcraft Helicopter with instrument rating.
• Airplane Rated: Airplane (Single-engine land or multi-engine land) with instrument.
• Helicopter Rated: Rotorcraft Helicopter with instrument rating.
• Equivalent military rating of the above at the time of application (eligibility based on military flight experience must provide official orders, forms or logbooks showing their status as a rated military pilot).

Flight Hours: Pilot Enter on Duty minimums are 1500 flight hours; (up to 500 hours can be waived, reducing the pilot enter on duty minimums to 1000 hours.

250 Pilot-in-Command hours; 75 Instrument hours; 75 Night hours (Flight Hour Waiver available, see Required Documents); and 100 Flight hours in the last 12 months This qualification requirement is currently being waived by OPM through August 5, 2025.

FAA Class 2 medical required for assessment dated within the last 12 calendar months; FAA Class 1, FAA Class 2 or Military medical flight clearance dated within the last 12 months qualifies to start the pre-employment process for the AIA position.

Apply at 750 hours total time: Applicants applying at 750 flight hours are required to obtain at least 1,000 flight hours (depending on the number of hours approved for a waiver) at their own expense before being able to attend the 3-part flight assessment. Applicants must still meet 250 Pilot-in-Command, 75 instrument, and 75-night hours (100 flight hours in the last 12 months. This qualification requirement is currently being waived by OPM through August 4, 2026)

UAS Flight Hours:Applicants may include UAS Predator A (MQ-1), Predator B (MQ-9) flight hours and Predator A (MQ-1), Predator B (MQ-9) or predator-based flight hours. These hours may be credited towards satisfying the ""Total flight time"" 1,500 flight hour requirement only. UAS hours do not count towards the 250 flight hours as a Pilot in Command, 75 flight hours Instrument, and 75 flight hours Night. Flight hour logbooks will be required at the time of your Flight Assessment for verification.

Other Requirements

Citizenship: You must be a U.S. Citizen to apply for this position.

Residency: You must have had primary U.S. residency (includes protectorates as declared under international law) for at least three of the last five years.

Age Requirement: Provisions of Public Laws 93-350 and 100-238 allow the imposition of a maximum age for initial appointment to a primary Law Enforcement Officer position within the Department of Homeland Security (DHS). In accordance with DHS Management Directive 251-03, the ""day before an individual's 37th birthday"" is the maximum age for original appointment to a position as a primary law enforcement officer within DHS. The age requirement is also necessary to ensure that you are able to complete the 20 years of applicable service for retirement.

NOTE: The Commissioner of CBP has approved a temporary increase in the maximum allowable age to 40 for original placement into an Air Interdiction Agent position.

Age Waiver: Creditable law enforcement officer service -Covered by Title 5 U.S.C. 8336(c) or Title 5 U.S.C. 8412(d), or creditable service covered by Title 5 U.S.C. 8401(36) (as a Customs and Border Protection Officer) on or after July 6, 2008, may be applied toward the maximum age requirement. This age restriction may not apply if you are currently serving in a federal civilian (not military) law enforcement position covered by Title 5 U.S.C. 8336(c) or Title 5 U.S.C. 8412(d).

Veterans' Preference Eligibility: To ensure compliance with statutes pertaining to the appointment of preference eligible veterans as determined by the Merit Systems Protection Board in its decisionIsabellav.Dept of State,the maximum age for original appointment articulated above shall not apply to the hiring of individuals entitled to veterans' preference eligibility under 5 U.S.C. 3312. You must submit proof of Veteran's Preference (DD-214 Member 4 Copy) at the time of application.

Training:This position has a training requirement. You may be required to successfully complete the training requirement as a condition of employment. Failure to successfully complete the required course(s) of training in accordance with CBP standards and policies will result in placement into either a former or different position, demotion, or separation as determined by management and appropriate procedures.

Travel Required: You may be expected to travel for this position based on operational needs.

How to Apply

There Are Three Ways to Apply to Become an Air Interdiction Agent:

• Fill out theAir Interdiction Agent applicant checklistand email it to a recruiter at along with a copy of your resume; OR

• Apply onUSAJOBS;OR

• Apply onAirline Apps.

Stay Updated Opt into CBPs talent repository (highly recommended) by selecting the Contact a Recruiter button. For Position of Interest select Air and Marine Operations, Air Interdiction Agent, then complete the pre-screening questions. Youll receive monthly emails with information about webinars, career expos, and future opportunities with AMO and CBP.

• Government & Military

Akkodis is seeking Health & Safety Specialist in Durham NC 27703

Job Title: Health & Safety Specialist

Location: Durham NC 27703

Pay Range:$36/hr - 43.50/hr (The pay range may be negotiable based on experience, education, geographic location, and other factors)

Duration : 12 Months Contract

Job Description:

• Assist in the development and implementation of the site’s EHS programs and procedures to ensure compliance with local, state, federal requirements.
• Provide EHS-related training to colleagues and contractors, including new-hire EHS orientation and refresher training.
• Design and lead the EHS FOCUS program (including annual refresher training [Talk]; monthly Walk activities; supervisor inspections [Detect]; process confirmation [Check]; and award recognition [Together]). Analyze data to continuously improve the program. Provide routine reports to management.
• Develop and implement programs to improve the site’s EHS culture and compliance -- including behavior based safety; ergonomic awareness, evaluations and solutions; pre-shift workplace stretching; and good catch/near-miss/concern reporting.
• Manage the Durham site’s VPP Program application to successfully meet NC OSHA requirements for Carolina Star including hosting inspections, audits, document preparation, etc.
• Provide EHS expertise and support to dispersed workforce (e.g., technicians, sales force, veterinary staff, etc.) of Cattle, Poultry and Swine USA operations. Host monthly safety meetings with colleagues. Complete periodic ride-along visits to observe colleague’s field operations and ensure implementation of EHS programs. Provide recommendations for safety improvements aimed at reducing risks, improving safety culture, ensuring compliance, and reducing injuries. Manage injury logs, workers compensation filings and internal reporting requirements,
• Conduct routine site audits, safety walks, environmental inspections and other related evaluations (as needed) to identify systemic EHS management gaps. Develop and track corrective measures and implement solutions to sustain compliance.
• Manage and report EHS-related information (injury/illness, environmental metrics, risk assessments, EHS action items) into the Company’s EHS online system (Cority). Submit all EHS reports as required by regulatory authorities.
• Participate on injury/illness investigations and identify root cause and corrective/preventive actions. Provide coaching on practical EHS behaviors, work practices and solutions.
• Develops EHS notices, postings, newsletter and other communications, as requested.
• Participate on the site’s Emergency Response Team and Safety Committee.
• This role will report to the site’s EHS & Facility Manager and will interact with Operations, Manufacturing, R&D, Facilities, Engineering, Quality, Distribution and office operations including working with all levels of the organization and be visible in the operational areas to support a safe and compliant work environment.
• Bachelor’s degree in environment, safety, occupational health, ergonomics, engineering or a similar technical discipline.
• Minimum of five (5) year of EHS-related experience. (Open to new graduate with related internship or job shadow experience).
• Professional certification (CSP, CIH) preferred.
• Thorough knowledge and interpretation of federal and North Carolina safety and environmental regulations and programs including Carolina VPP Star.
• Strong interpersonal and diplomacy skills, leadership, analysis, judgment, creativity, practical problem solving, flexibility, as well as excellent written and oral communication skills.
• Solid computer capabilities including Microsoft Word, Excel, PowerPoint and SharePoint.
• Ability to facilitate meetings, perform multiple tasks simultaneously, work independently, easily make decisions, and handle emergency situations.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance

Puneet Rajput

Resource Development Manager

T

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Akkodis is a commercial brand under which both AKKA & Modis entities operate.

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• Pursuing opportunities at institutions such as Naval Postgraduate School (NPS) or Navy War College (NWC)
• Completing Joint Professional Military Education (JPME) at one of the various service colleges

EHS Consultant — Global Engineering Construction Projects

Position Overview

Intuitive Safety Solutions (ISS) is seeking an experienced Environmental, Health & Safety (EHS) Consultant to support a large-scale construction project within a global engineering environment. This role provides governance, oversight, and strategic safety leadership throughout project planning, mobilization, and execution phases.

The EHS Consultant will function as a trusted advisor to project leadership, working closely with Construction Management (CM), General Contractors (GC), and operations stakeholders to ensure effective implementation of safety programs and alignment with Global Engineering Safety & Health Assurance expectations.

This position blends administrative leadership with field engagement, focusing on proactive risk management, safety culture development, and performance monitoring across multi-employer construction environments.

Reporting Structure

• Functional reporting to the Project Manager.
• Secondary reporting to the Americas Lead for Global Engineering Construction Safety.
• Close collaboration with Operations Safety teams and project stakeholders.

Work Environment

• Approximately 75% office/administrative responsibilities.
• Approximately 25% field-based engagement supporting project safety oversight.

Project Phases & Responsibilities

Early Stage Planning (March–April | ~8–16 hours/week)

• Provide project orientations and safety indoctrination sessions for project teams and construction management personnel.
• Support CM/GC teams with lower-tier contractor outreach and onboarding alignment.
• Assist in reviewing early safety and health project plan submittals for compliance with regulatory and organizational requirements.
• Contribute to early risk planning and safety program alignment.

Execution & Mobilization (May–June onward | Full-Time | 40 hours/week)

• Lead periodic project safety meetings and contribute to weekly project tier meetings.
• Participate in Global Engineering safety peer forums and knowledge-sharing initiatives.
• Review pre-planning safety documentation including JHAs, AHAs, and RAMs for regulatory compliance and adherence to Global Engineering Safety & Health Assurance Program standards.
• Conduct periodic team walks to evaluate field safety performance and compliance.
• Perform documented audits, inspections, and performance assessments.
• Monitor CM efforts to establish and maintain a strong safety culture, including workforce understanding and perception.
• Track leading indicators, analyze trends, and provide insight to project leadership.
• Provide governance and oversight for root cause investigations and corrective actions following incidents.
• Support alignment between construction execution teams and global safety expectations.

Required Qualifications

• Minimum 10+ years of environmental, health, and safety experience with strong emphasis on construction safety.
• Experience supporting multi-employer construction environments.
• Demonstrated leadership presence and ability to influence across multiple organizations.
• Strong knowledge of OSHA Construction regulations and regulatory compliance frameworks.
• Excellent communication skills with ability to engage both executive stakeholders and field teams.
• Strong analytical and reporting capabilities.

Preferred Qualifications

• 2–3+ years in a leadership or oversight role on complex construction projects.
• Experience in highly regulated or mission-critical environments such as:
• Pharmaceuticals
• Biotechnology
• Data center construction
• Oil & gas
• Chemical or industrial facilities
• Associate or Bachelor’s degree in Occupational Safety & Health or related field.
• Nationally recognized certification such as:
• BCSP CSP
• BCSP CSM
• BCSP CHST
• BCSP CSHM
• BCSP ASP
• NASP MSP
• NASP CSD

Key Traits for Success

• Strong governance mindset balanced with practical field awareness.
• Ability to influence without direct authority.
• Analytical thinker focused on leading indicators and proactive risk reduction.
• Collaborative leader who builds alignment across diverse teams.
• Detail-oriented with strong documentation and reporting skills.

Recruiters please do not contact this job poster. Please be advised: Solvias does not accept unsolicited resumes or services from third-party recruitment agencies. In the event, a recruiter or agency submits a resume or candidate without an agreement we shall explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to Company employees, shall be deemed the property of the Company.

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards.

Position Overview

The Head of Strategy & Portfolio – Large Molecules is the segment owner for strategy and portfolio decisions, accountable for defining where to play, how to win, and how to allocate capital across the Large Molecules business.

The role drives organic and inorganic growth by translating market, customer, and financial insights into clear portfolio choices and investment priorities, while partnering closely with Marketing, Sales, Finance, Science, and Operations to ensure disciplined execution aligned with Solvias’ growth ambitions.

Segment Strategy & Growth

• Own and continuously refine the 5-year strategic roadmap for the Large Molecules segment, including growth priorities, capability gaps, and capital allocation logic
• Translate corporate strategy into explicit segment-level choices and trade-offs, with measurable outcomes
• Lead strategic scenario planning and performance tracking; report progress and implications regularly to the Executive Committee
• Act as strategic owner for cross-functional initiatives (e.g., digital enablement, footprint optimization) that materially impact Large Molecules scalability or economic

Portfolio & Investment Governance (Core Accountability)

• Own portfolio governance for the Large Molecules segment, including decisions to invest, scale, maintain, partner, or exit services
• Lead business cases for new service development, major capacity or capability investments, portfolio rationalization and long-tail management
• Track portfolio performance by service, customer segment, and site, in close collaboration with Finance
• Trigger corrective actions where ROI, margin, or strategic relevance thresholds are not met
• Ensure client acquisition priorities are aligned with portfolio strategy, in partnership with Marketing and Sales Leadership

Inorganic Growth & Partnerships

• Define M&A strategy and screening criteria for the Large Molecules segment
• Own target scouting, strategic fit assessment, and prioritization prior to handover to deal execution teams
• Support synergy logic and value-creation roadmap development
• Assess strategic partnerships that accelerate capability build-out or market access, in alignment with EC

Go-to-Market Strategy (Strategic guardrails, not Execution)

• Own market and competitive insights for the Large Molecules segment; ensure insights inform strategy, portfolio decisions, and GTM prioritization
• Define target segments and sources of differentiation; partner with Marketing to articulate and activate compelling value propositions through messaging, campaigns, and commercial tools
• Define pricing principles and governance frameworks for the segment; support Finance and Commercial teams on strategic pricing decisions and exceptions

Requirements

• Bachelor's degree in science, engineering, or business. Master's or higher degree is preferred.
• 10+ years of experience in Strategy, Portfolio Management, Marketing Strategy, Business Development, or Consulting
• Experience owning or shaping a multi-service portfolio with clear ROI and lifecycle accountability
• Exposure to pharmaceutical, CRO/CTO, CDMO, or life sciences services strongly preferred
• Core Skills: Strategic planning & trade-off analysis, portfolio economics & financial modeling, market & competitive intelligence, executive-level communication and stakeholder influence

Other Desired Skills/Abilities

• Proficiency in English; additional languages (esp. German, French, Mandarin) are a plus.

NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias USA, LLC does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

Responsibilities:

• Collaborate with Accounting and Finance team to effectively manage the budgeting & forecasting process.
• Closely monitor & communicate to the Vice President; Project Status/Risks & Opportunities.
• Participate in management committee meetings within all assigned joint ventures.
• Manage the pursuit of project claims & change orders.
• Responsible for ensuring the development & use of a CPM schedule throughout the life of the project.
• Engage project and corporate level contract management to address & resolve contractual issues & claims.
• Participate in project level staff meetings and all major decisions.
• Establish & promote a safety culture through active representation.
• Oversee procurement or Buy-out process to ensure it adhere to set budget.
• Sponsor additional revenue strategy including REA's and claims.
• Establish and maintain relationships with key business partners.
• Effectively oversee subcontract management.
• Coach and develop staff.
• Carry out job duties while maintaining Lane values

Qualifications:

• Bachelor's Degree in Civil Engineering, Construction Management or related field.
• Minimum 15 years heavy civil construction experience.
• Excellent written and verbal communication skills.
• Ability to assess, evaluate, and solve problems.
• Knowledge of regulatory laws and responsibilities.
• Organizational skills; attention to detail.
• Teamwork and leadership skills.

Senior Systems Engineer

Gilero is a leading medical device design, development, and manufacturing partner. We specialize in creating innovative solutions that improve patient care and enhance lives. Our growing dynamic team of professionals works across disciplines to bring ideas to life, from concept to commercialization.

We are seeking a highly skilled Senior/Staff Systems Engineer to lead and contribute to the development of complex medical devices and combination products. The ideal candidate will bring a systems-level perspective, integrating mechanical, electrical, and software components while ensuring compliance with regulatory and quality standards. You will be responsible for leading systems engineering project activities for medical device and drug delivery applications. This role is pivotal in bridging engineering disciplines to deliver safe, effective, and innovative healthcare solutions.

Join us in a collaborative and innovative environment where your contributions will make a real difference. You'll work with multiple clients across a variety of cutting-edge products to help shape the future of healthcare technology, ensuring products meet the highest standards and positively impact patient outcomes across the globe.

Responsibilities:

• Acts as technical lead throughout the full product development lifecycle from initial concept to release to market of new medical devices; primarily class I and class II electro-mechanical devices.
• Provides expertise in various Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, change management, and reliability.
• Plans systems engineering projects by identifying appropriate system development lifecycles.
• Develops product development strategies for large or complex systems integrations.
• Generates system architecture definitions, integrations, development viewpoints, and models.
• Manages the system architecture and relates it to the design throughout the lifecycle.
• Defines requirements hierarchy and how it relates to verification and validation planning.
• Performs functional system decompositions to solve complex design challenges.
• Prepares detailed component and assembly drawings. Leads and participates in writing product and customer requirements, design and phase reviews, product and process risk assessments, root cause investigations, and corrective action planning.
• Plans, authors, and executes test methods and protocols for design verification and validation.
• Analyzes test data, interprets results, and formulates conclusions.
• Maintains the Design History File (DHF) and ensures documents are complete, accurate, current, and compliant with regulations.
• Contributes to developing systems engineering tools and processes and trains others to use those systems.
• Identifies technical opportunities and generates work for themselves within their assigned project teams.
• Defines objectives, participates in, and oversees the quality of output for large or complex projects.
• Contributes to solving open-ended problems and tasks with a high level of decision-making.
• Formulates and develops detailed project deliverables with some management oversight.
• Communicates technical risks and proposed solutions clearly and directly with the customer.
• Sources and interfaces with third-party vendors.
• Acts as subject matter expert (SME) lead in one or more areas and is aware of industry trends.
• Supports business development efforts as a SME to potential customers and providing input on engineering estimations.
• Establishes a proven track record of building trust and rapport with new clients.
• Acts as mentor demonstrating strong leadership skills.
• Participates in recruitment activities including interview panels.
• Travel will be required, as necessary (typically less than 5%).

Skills/Qualifications:

• BS in Engineering or equivalent technical degree.
• Work onsite in the Durham, NC office four days per week.
• 5+ years relevant experience.
• Experience developing electro-mechanical medical devices.
• Proven ability to lead a product development program from concept to market release.
• Working knowledge of system modeling tools and methodologies (e.g., UML, SysML).
• Working knowledge of working in both agile and waterfall methodologies.
• Proficiency with SolidWorks or other 3D CAD (Computer Aided Design) modeling software.
• Working knowledge of requirements management software (e.g., Jama, Polarion, Doors).
• Working knowledge of developing products for compliance with IEC 60601 for electrical safety and for software development.
• Working knowledge of developing products for compliance with FDA 21 CFR Part 820.30, 21.
• CFR Part 4, ISO14971, ISO 13485 and EU MD.

Personal Attributes:

• Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity.
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements.

Eligibility To Work:

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero:

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.

Associate Scientist

Location: Durham, NC

Focus: Retinal Disease & AAV Platforms

Role Summary

We are seeking a versatile Associate Scientist to drive the design and execution of molecular and cell biology experiments centered on AAV-based retinal gene therapies. This role is a hybrid of innovative R&D and operational leadership; you will transition between conducting high-stakes experiments at the bench and overseeing laboratory operations, including budget management, vendor sourcing, and regulatory compliance.

Primary Responsibilities

• Experimental Design & Execution: Develop and maintain complex mammalian cell models (including iPSC, human, and animal lines) to support in vitro disease modeling.
• Gene Therapy Validation: Lead molecular assays to evaluate the efficacy of AAV vectors and small molecules using dPCR, protein quantification, and functional potency assays.
• Data Strategy: Meticulously document, interpret, and present experimental findings to cross-functional scientific teams.
• Laboratory Operations: Manage the R&D budget, oversee procurement, coordinate with external service providers, and maintain instrumentation to ensure a seamless research environment.
• Quality & Compliance: Author and refine SOPs, technical reports, and protocols while ensuring the lab strictly adheres to safety and regulatory standards.

Technical Qualifications

• Cellular Modeling: Extensive hands-on experience with mammalian and iPSC culture. (Specific experience with retinal models or potency assays is highly preferred).
• Molecular Toolbox: Proficiency in cloning, qPCR/dPCR, Western Blotting, and ELISA.
• Digital Fluency: Advanced skill in data analysis and design software, including GraphPad Prism, SnapGene, and the MS Office Suite.
• Operational Mindset: Proven ability to manage lab inventory and equipment in a fast-paced, collaborative startup or biotech environment.

Education & Experience

• Degree: B.S. or M.S. in Neuroscience, Ophthalmology, Molecular Biology, Biomedical Engineering, or a related discipline.
• Experience: A minimum of 4 years of hands-on laboratory experience.
• Preferred Skills: Direct experience with viral vectors (AAV/Lentivirus) and the full lifecycle of iPSC management (culture, clone selection, and banking).