Engineering Jobs in Colmar

Logistics Planner Specialist II

Location(s): West Point, PA; Rahway, NJ

Work Environment: Hybrid

Job Summary:

The Logistics Planner Specialist II is responsible for driving tasks to completion and mentoring junior staff. This role requires a heightened level of autonomy and strong business acumen. The Logistics Planning Specialist will be responsible for supporting and work cross-functionally with, but not limited to, Clinical Supply Planning, Country Clinical Operations, CMOs/CROs, Distribution, Regulatory, External Operations Management, Operational Expense Management, Trade Operations, and Trade Compliance to support and plan distribution for Clinical Trial Material utilizing approved depot networks. Act as the Logistics Planner and develop distribution plans and execute activities for network preparedness of distribution activities. Communicate with all constituents and be the advocate for the distribution strategy for clinical trials. In addition to typical distribution planning activities, the individual will also be responsible for alignment of the lead-time and routing in SAP, and cost analysis for distribution network selection. Collaborate across functions and contribute to cross-functional initiatives, and, where appropriate, assume leadership of low-to-moderate complexity projects to drive defined outcomes.

Key Responsibilities:

• Drive tasks to completion amidst ambiguity.
• Mentor junior staff and provide guidance on project management.
• Collaborate across functions to achieve business objectives.
• Ownership of SAP-related processes that Logistics Planning is accountable
• Project Contributor, and at times lead, for both internal and cross-functional projects
• Proficient in cGMP
• Ability to function in a team environment and pursue information when it is not readily available.
• Communicate with all constituents and be the advocate for the clinical trial distribution strategy
• Partner with Clinical Supply Planning and Distribution Centers to oversee and implement distribution planning documents for clinical study protocols
• Represent Logistics Planning at internal communication meetings
• Serve as the functional area expert on country shipping and trade compliance, distribution routes, country and global distribution challenges
• Adherence to regulatory, global and site policies and procedures governing operations activities are critical.

Qualifications:

• Bachelor's degree preferred; candidates with relevant experience may be considered.
• 3+ years of experience in a related field; candidates without a degree should have 6+ years of relevant experience.

General Skills:

• Strong communication and proficient project management skills.
• Ability to collaborate across functions and teams.
• Analytical thinking and problem-solving skills.
• Detail-oriented with the ability to prioritize tasks effectively.

Unique Responsibilities:

• Ability to make connections at a higher level within the function.
• Self-motivated with the ability to mentor others.

Metrology Specialist I

On-site in West Point PA

Summary:

• Manage equipment assets at multiple locations
• Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions
• Participate in computer system validation activities associated with new or upgraded equipment or software packages.
• Originate and progress Deviations and Change Control records
• Perform and document investigations and assist in developing and implementing CAPA plans
• Contribute to new SOP drafting, implementation, and revisions.
• Represent the laboratory on all aspects of laboratory equipment during audits.
• Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures.
• Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.
• Willingness and ability to quickly upskill in Merck Facilities/Instrument support programs SAP, ProCal, BAS, LAMP, Electronic Validation, and other document and/or asset repositories
• Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment.

Calibration Focus:

• Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation.
• Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships.
• Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support.

Support the purchase, installation, and equipment qualification of new laboratory equipment.

*** There will be training opportunities to support Validation*** Validation activities are included below

• Support primarily the qualification/validation of computerized analytical systems as per current guidelines.
• Partner with the business unit in the laboratories, various quality support oversight, IT technical support, and various software and instrument vendors/manufacturers.
• Perform any required change control during the life cycle of a computerized system.
• Decommission systems as required as part of the equipment qualification/validation life cycle.
• Manage the capital purchasing and initial installation of computerized analytical systems prior to validation.
• Participate in various data integrity and lab modernization activities as required.
• Will possess direct experience operating analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large molecule focus).
• Will have the ability to thoroughly review and scrutinize validation requirements through the life cycle of the system.

General Requirements Level 1:

-Bachelor’s degree in biological or chemical science and/or engineering plus

-2-4 years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification

-Experience working in a GMP environment and maintaining laboratory equipment.

-Highly organized, strong communication skills.

-Capable of working independently.

-Solutions orientated mindset with the ability to handle multiple high priority tasks at one time.

-Ability to succeed in a dynamic environment; flexibility to respond to changing priorities.

-Awareness to independently prioritize tasks and responsibilities based on actual or perceived level of importance and/or potential impact to the GMP environment.

JOB OVERVIEW:

The Validation Scientist position encompasses all areas of Technical Services with primary focus on technology transfer, scale-up, process optimization, process/packaging validation, commercial production technical support as well as equipment qualification and cleaning validation support.

KEY ROLES/RESPONSIBILITIES:

• Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
• Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
• Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
• Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
• Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
• Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, principles, concepts, equations as well as statistical techniques.
• Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
• Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
• Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
• Represent Technical Services at project team meetings and provide sound technical advice.
• Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
• Directly interact with Piramal Pharma Solutions clients.
• Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.

EXPERIENCE:

• Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
• Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulates, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
• Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidance, and general compliance expectations.
• Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
• Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
• Technical writing experience is required with attention to detail skills essential.
• Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
• Must have proficiency in the Microsoft Office Suite programs.
• Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
• Ability to work effectively managing multi projects at a fast pace withcross-functional departments and manage priorities to meet timelines.
• Must be innovative, proactive, resourceful and committed to continuous improvement.
• Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.

WORK ENVIRONMENT:

The position requires the ability to work in ahigh demand office and manufacturing setting with time spent performing "on the floor" activities in laboratory and manufacturing areas. The position may require extended hours including evenings and weekends as well as work hours on 2nd and 3rd shifts depending on project needs.

Avo Photonics ( ) is a dynamic contract engineering services company that designs, develops, and manufactures custom opto-electronic products for a large customer base. Members of our staff have the opportunity to design, prototype and produce next generation products for a diverse range of markets including environmental, medical, military, industrial, aerospace, and communications.

We seek a diligent, dedicated, and meticulous person who will help to further our success and reputation in the industry. The successful candidate must plan his/her own work schedule to meet project deadlines, keep multiple records, be self-motivated and detail oriented, maintain a professional presence, and have the desire to take ownership of projects.

Specifically:

• Manage Teams responsible for all materials including incoming inspection, inventory (stock room and manufacturing floor), reject control
• Lead and manage the incoming inspection process for all materials and components, ensuring timeliness and compliance with quality standards and specifications
• Communicate issues to Procurement
• Oversee inventory organization and ensure timely distribution of materials on a 24/7 basis
• Manage materials reconciliation processes to ensure accuracy and consistency
• Conduct root cause analysis for inventory discrepancies and implement corrective actions
• Understand and control rejected material returned to the inventory room and ensure proper and timely disposition
• Partner with Procurement Manager to return rejected material discovered on production floor
• Support accounting of recovered materials
• Be highly organized and efficient at prioritizing workload

Requirements:

• BS in business, accounting, operations, or related discipline
• 10 years experience with management of Materials in a manufacturing environment
• Expertise with an ERP system (SAP preferred)
• 7 years management experience of small teams
• Experience operating within an ISO9001-certified company
• Outstanding verbal and written English communication skills
• Attributes: High attention to detail, organized, able to multitask, personable, motivated, willing to take initiative

Apply: Avo Photonics offers competitive salaries and a comprehensive benefits package. Qualified candidates are encouraged to apply!

Equal Opportunity Employer: Avo Photonics is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee of Avo Photonics by any method without a valid written contract in place with Avo Photonics will be deemed the sole property of Avo Photonics. No fee will be paid in the event the candidate is hired by Avo Photonics because of the referral or through any other means.

• 
  Performs patient procedures within the nursing scope of practice.
  

• 
  Practices safe medication administration and assesses patient responses to medication.
  

• 
  Participates in reviewing and/or implementing clinical pathways and care coordination.
  

• 
  BSN Degree p referred
  

• 
  State Issued RN license
  

• 
  Basic Life Support (BLS) certification from the American Heart Association
  
• 
  ICU experience strongly preferred
  

By applying, you consent to your information being transmitted to the Employer by SonicJobs.
See Jefferson Health Privacy Policy at and SonicJobs Privacy Policy at and Terms of Use at

Senior Commissioning & Qualification Engineer – Automation (Biopharma Build)

Owner’s Representative | Onsite – Spring House, PA

Contract through end of year, potential for ongoing extensions

We are seeking a senior Commissioning & Qualification (C&Q) Automation SME to support the delivery of a state-of-the-art Cell & Gene Therapy manufacturing facility.

This is a high-visibility, onsite role where you will serve as the Owner’s Representative, ensuring highly automated GMP process systems are properly commissioned, integrated, and inspection-ready. If you thrive in complex, automation-heavy capital projects, this is the type of build that defines careers.

What You’ll Be Doing

• Act as the technical SME for commissioning automated process equipment
• Represent the owner’s interests across all project phases
• Lead execution of Commissioning Plans with emphasis on automation, integration, and data integrity
• Author and review IQ/OQ/PQ protocols, URS, and validation documentation
• Oversee startup and field execution for complex equipment platforms
• Drive resolution of automation-related deviations and integration issues
• Coordinate across automation, construction, validation, quality, and vendor teams
• Apply risk-based qualification principles (ASTM E2500, FMEA)
• Ensure compliance with GMP, FDA, and 21 CFR Part 11
• Support digital validation platforms (e.g., Kneat)

Equipment & Systems Scope

• Cell & gene therapy manufacturing systems
• Fill/Finish lines
• Isolators
• Integrated process equipment platforms
• PLC / SCADA / DCS automation layers

What We’re Looking For

Required:

• Bachelor’s degree in Engineering or Life Sciences
• 5–10 years of CQV experience in automated biopharma manufacturing
• Hands-on experience with process equipment and control systems
• Strong understanding of GMP validation lifecycle

Strongly Preferred:

• DeltaV, Rockwell, Siemens, or similar DCS/PLC platforms
• Experience in greenfield or large capital projects
• ASTM E2500 / GAMP 5 knowledge
• Experience with digital validation tools (Kneat, Veeva)
• Background in cell & gene therapy, fill/finish, or cleanroom environments

Why This Role?

• High-impact, automation-heavy greenfield project
• Owner-side authority and visibility
• Complex, integrated GMP systems
• Opportunity to shape commissioning strategy at a flagship facility

EEO Statement:

• Eight Eleven Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

Pengate Handling Systems is a full-service provider of material handling equipment and solutions, helping businesses move, store, and manage products more efficiently. We design, build, and install conveyors, automation systems, and custom storage solutions tailored to each client’s operational needs. Our projects improve workflow, boost productivity, and enhance safety, delivering real, measurable results. With expertise across industries, we combine engineering know-how with hands-on experience to create systems that solve complex challenges and keep businesses running smoothly.

We are seeking a results-driven Optimization Specialist to drive operational excellence across our field operations. This role champions Lean methodologies, streamlines processes, and improves cross-functional performance while delivering measurable business impact.

What You’ll Do

• Lead Lean initiatives using tools such as Kaizen, 5 Why analysis, Process Mapping, 5S, Gemba walks, PDCA, Value Stream Mapping, A3, and Root Cause Analysis.
• Conduct process assessments, identify opportunities for improvement, and implement sustainable solutions.
• Partner with leaders across Service, Dispatch, Parts, Rental, and Logistics to streamline workflows and eliminate bottlenecks.
• Standardize processes, develop staffing and resource forecasts, and optimize utilization.
• Analyze operational data to uncover trends, measure performance, and drive continuous improvement initiatives.
• Lead root cause analyses to resolve operational challenges and prevent recurrence.
• Sponsor and oversee optimization projects with defined metrics, measurable ROI, and clear success criteria.
• Strengthen cross-functional communication and collaboration to improve alignment and workflow integration.
• Implement best practices for workflow efficiency, resource allocation, and process standardization.
• Develop dashboards, KPIs, and reporting frameworks to monitor performance and guide strategic decisions.
• Mentor and influence teams to adopt Lean thinking, operational discipline, and problem-solving mindset.
• Support change management initiatives and promote a culture of continuous learning and improvement.

What We’re Looking For

• Bachelor’s degree in Business, Operations, Logistics, or a related field.
• 3+ years of operational experience, preferably in service-based or field operations.
• Proven success improving fleet utilization and driving cross-department collaboration.
• Experience with dispatch systems, fleet tracking tools, and operational metrics.
• Strong analytical skills with the ability to interpret data, identify trends, and develop actionable insights.
• Excellent problem-solving and decision-making abilities, including root cause analysis.
• Expertise in Lean methodologies, continuous improvement, and process optimization.
• Strong project management skills with the ability to prioritize and manage multiple initiatives simultaneously.
• Exceptional organizational skills and attention to detail.
• Effective communicator capable of presenting ideas clearly to both technical and non-technical audiences.

Why Work at Pengate

• Join a team that values innovation, collaboration, and continuous improvement.
• Work in an environment where your ideas are heard and make an impact.
• Lead meaningful projects and contribute to operational excellence across the organization.
• Grow your skills through opportunities in Lean practices, data-driven decision making, and process optimization.
• Be part of a company that recognizes and celebrates success, both individually and as a team.
• Thrive in a culture that fosters professional development and continuous learning.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and company holidays.
• Opportunities for professional development, training, and certifications.
• Supportive and collaborative work environment.

Pengate Handling Systems is dedicated to being an Equal Opportunity Employer. We promote and celebrate a diverse workforce and do not tolerate any discrimination. All human relations decisions will not be based on persons’ race, color, religion, sex, national original, marital status, disability, genetic information, age, veteran status, or citizenship. All potential hires are subject to pre-employment checks which include but are not limited to background checks and drug screenings. In addition, we will provide reasonable accommodations for individuals with disabilities. Should you require an accommodation in completing an application, interview, or pre-employment requirement, please reach out to our Talent Acquisition team at

About Precis

Precis Engineering + Architecture (Precis) is a 150+ person consulting firm with offices in Ambler, Pa., and Cary, N.C., offering comprehensive design services. Precis has been repeatedly recognized as a Best Place to Work by the Philadelphia Business Journal.

Description:

Precis Engineering + Architecture (Precis) ( ) offers comprehensive design services to our clients in the pharmaceutical, biotechnology, higher education, industrial, commercial, critical utility, and healthcare markets. Together, we design and create important buildings, facilities, and environments that improve and save lives.

Precis is recognized for our design expertise and proficiency in providing strategically sensitive and technically complex engineering and architectural services. The Mechanical Department is regularly engaged in a broad spectrum of projects that require creative solutions to challenging building systems and utility issues. This offers an excellent environment for employees to rapidly expand their knowledge and understanding of the key role engineering plays in the success of building renovations and new construction projects.

Precis is currently seeking a Senior Mechanical Engineer for our Ambler, PA office. This individual must have a background in Mechanical/HVAC Engineering and a basic understanding of engineering practice within highly regulated industries. We are looking for a resourceful and goal-oriented individual who desires challenging work in a dynamic environment.

Responsibilities:

• Provide mechanical engineering services to design and oversee the design of complete mechanical/HVAC systems supporting facility expansions, renovations, remediation, and new construction projects from concept through detailed design and construction, including equipment, ductwork, piping, building automation, and related building components.
• Receive supervision and guidance relating to overall objectives, critical issues, new concepts, and policy matters. Receive direction on unusual conditions and developments.
• Independently apply extensive and diversified knowledge and use advanced techniques in the modification or extension of standard procedures and design criteria to complete assignments, including the development of details, control sequences, and specifications. Assist upper-level management to develop new techniques and improve standards and processes.
• Supervise all staff necessary to complete project assignments in alignment the defined scopes, schedules, and budgets. Provide thorough review of project documents for conformity with project assignments and quality assurance.
• Interact with client representatives, equipment vendors, contractors, project managers, and other project team members to coordinate deliverables and breadth of the mechanical design.
• Periodically visit project sites to survey existing conditions and observe construction activities.

Requirements:

• Bachelor of Science degree in Mechanical or Architectural Engineering
• Minimum 8 years industry engineering experience
• Strong computer literacy with advanced knowledge and use of Excel, Word, Outlook, and Teams
• Advanced written & verbal communication skills
• Advanced knowledge of applicable codes and industry standards and guidelines
• Experience with critical environments and related building systems
• Professional Engineer license

Why Join Precis?

• Be part of a collaborative, innovative team that values your ideas and expertise.
• Shape growth for a respected, specialized engineering and architecture firm.
• Enjoy a flexible, supportive work environment and competitive compensation package.

Equal Opportunity Employer

Precis provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.

About Precis

Precis Engineering + Architecture (Precis) is a 150+ person consulting firm with offices in Ambler, Pa., and Cary, N.C., offering comprehensive design services. Precis has been repeatedly recognized as a Best Place to Work by the Philadelphia Business Journal.

Description:

Precis Engineering + Architecture (Precis) ( ) offers comprehensive design services to our clients in the pharmaceutical, biotechnology, higher education, industrial, commercial, critical utility, and healthcare markets. Together, we design and create important buildings, facilities, and environments that improve and save lives.

Precis is recognized for our design expertise and proficiency in providing strategically sensitive and technically complex engineering and architectural services. The Plumbing Department is regularly engaged in a broad spectrum of projects that require creative solutions to challenging building systems and utility issues. This offers an excellent environment for employees to rapidly expand their knowledge and understanding of the key role engineering plays in the success of building renovations and new construction projects.

Precis is currently seeking a Senior Plumbing Engineer for our Ambler, PA office. This individual must have a background in Plumbing Engineering and a basic understanding of engineering practice within highly regulated industries. We are looking for a resourceful and goal-oriented individual who desires challenging work in a dynamic environment.

Responsibilities:

• Provide plumbing engineering services to design and oversee the design of complete plumbing systems supporting facility expansions, renovations, remediation, and new construction projects from concept through detailed design and construction, including equipment, piping, and related building components.
• Receive supervision and guidance relating to overall objectives, critical issues, new concepts, and policy matters. Receive direction on unusual conditions and developments. Independently apply extensive and diversified knowledge and use advanced techniques in the modification or extension of standard procedures and design criteria to complete assignments, including the development of details, and specifications. Assist upper-level management to develop new techniques and improve standards and processes.
• Supervise all staff necessary to complete project assignments in alignment the defined scopes, schedules, and budgets. Provide thorough review of project documents for conformity with project assignments and quality assurance.
• Interact with client representatives, equipment vendors, contractors, project managers, and other project team members to coordinate deliverables and breadth of the plumbing design.
• Periodically visit project sites to survey existing conditions and observe construction activities.

Requirements:

• Bachelor of Science degree in Mechanical or Architectural Engineering, or an Associate degree in a related field.
• Minimum 8 years of industry engineering experience.
• Strong computer literacy with advanced knowledge and use of Excel, Word, Outlook, Teams, AutoCAD, and Revit.
• Advanced written & verbal communication skills.
• Advanced knowledge of applicable codes and industry standards and guidelines.
• Experience with critical environments and related building systems.
• Professional Engineer license is a plus

Why Join Precis?

• Be part of a collaborative, innovative team that values your ideas and expertise.
• Shape growth for a respected, specialized engineering and architecture firm.
• Enjoy a flexible, supportive work environment and competitive compensation package.

Equal Opportunity Employer

Precis provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics