Engineering Journal Jobs in Durham Nc Remote

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. 

Hybrid - 4 days in office

About Our Client

Our client is a global, operations-driven organization operating in a complex manufacturing and supply network environment. They are investing in strengthening supply planning, inventory strategy, and SIOP capabilities to better balance service, cost, and risk across regions. This role sits at the center of those efforts and will have meaningful visibility and influence across the business.

The Opportunity

This is a highly impactful supply planning leadership role for someone who enjoys both running the planning engine and fixing what’s not working. The Supply Chain Manager will own finished goods (FG) and FF&P supply planning, ensuring demand signals, constraints, and inventory policies translate into executable, accurate plans. This person will partner closely with regional and global stakeholders, drive continuous improvement, and play a key role in scenario planning and decision support.

• Key ResponsibilitiesLead FG and FF&P supply planning, ensuring alignment with demand priorities, business rules, and operational constraints
• Own dependent requirements planning from FG to FF&P, generating netted AI demand signals and completing constrained supply plans
• Execute MRP with defined freeze periods to generate accurate planned orders; own demand netting within the supply region
• Manage MRP exception handling, validating and resolving issues sequentially and ensuring completeness and accuracy of MRP outputs
• Own FG and bulk inventory planning in partnership with Inventory Management, including lead times, safety stock, and inventory targets
• Implement and refine safety stock policies to balance service levels and working capital
• Prepare supply plans by reviewing planning data, netting policies, BoMs, capacity alignment, and data accuracy (including data cleaning and validation)
• Support the SIOP process by preparing inputs for regional supply reviews and incorporating allocation decisions and global constraints
• Perform scenario modeling to evaluate trade-offs, assess risks, and support data-driven decision-making
• Coordinate execution feasibility across key stakeholders, including Tollers, Material Planners, AI Planners, and Schedulers
• Validate intercompany transfer orders generated by MRP and ensure alignment with supply priorities and stock availability
• Proactively communicate supply risks and escalate critical shortages when resolution paths are not available
• Continuously improve planning processes, tools, and standards by challenging inefficiencies and implementing best practices

• What We’re Looking For5–10 years of experience in supply planning within a complex manufacturing or distribution environment
• CPIM certification strongly preferred
• Deep expertise in MRP and dependent requirements planning, including demand netting and exception management
• Strong experience working within ERP and advanced planning systems, with the ability to interpret outputs and optimize planning parameters
• Proven ability to manage cross-functional stakeholders and operate effectively in matrixed organizations
• Analytical, data-driven mindset with experience in scenario modeling, root-cause analysis, and continuous improvement
• Sound judgment and decision-making skills, balancing short-term constraints with long-term strategy and risk mitigation
• Strong communication skills, with the ability to present supply scenarios, trade-offs, and recommendations to senior leaders
• Detail-oriented planner who also maintains a strong big-picture perspective

Why This Role

This is an excellent opportunity for a supply planning professional who wants to move beyond pure execution and play a strategic role in improving how supply decisions are made. The right person will have the chance to influence systems, processes, and outcomes — not just maintain the status quo.

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.

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

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.