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Senior Process Engineer — Injector Pen Assembly Platform
RCM Technologies, Inc. | Life Sciences / Data & Solutions
- 🇺🇸 United States
- On-site
- Senior
- 2 days ago
- PFMEA
- Acceptance Testing
- Windows
- Technical Writing
2 days ago
Role: Senior Process Engineer — Injector Pen Assembly Platform
Compensation: Up to $85 hourly commensurate with experience
Location:Onsite (Raleigh/Durham area)
Length of Contract: Up to 1 year
Position Description
We are seeking an experienced Process Engineer to work with a leading biotech, focusing on Autoinjector Assembly: From component feeding to production scale assembly. In this role you serve as the client's technical representative for the cartridge assembly line, covering bulk component feeding, cartridge insertion, subassembly, final assembly and inspection. You will review and challenge technical inputs from the equipment supplier, own the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) strategy, and drive issues to closure so the line is delivered on time, validated and ready for commercial manufacturing.
Responsibilities
Technical Representation and Design Oversight
- Represent the client in technical discussions with equipment suppliers, integrators and internal stakeholders.
- Review and refine user requirements specifications (URS), process specifications and measurable equipment acceptance criteria.
- Review equipment layouts, design documents, functional specifications, component drawings, control narratives and inspection strategies.
- Evaluate component feeding, orientation, conveyance, cartridge handling and insertion, joining operations, final assembly and automated inspection.
- Assess equipment accessibility, maintainability, changeover, ergonomics, error-proofing and component/product protection.
- Participate in design reviews and process risk assessments, including process failure mode and effects analysis (PFMEA).
- Maintain traceability between requirements, design decisions, risks and acceptance testing.
Factory Acceptance Testing (FAT)
- Develop the FAT strategy, test plan, protocols and detailed test scripts with the client and equipment supplier.
- Define test prerequisites, representative components, challenge conditions, sampling approaches and acceptance criteria.
- Lead FAT execution at the supplier's facility and coordinate participation from Engineering, Manufacturing, Automation and Quality.
- Verify equipment functionality, assembly sequence, inspection performance, alarms, interlocks, reject handling, fault recovery and data capture.
- Assess agreed performance measures, including throughput, cycle time, yield, component damage and sustained operating capability.
- Document results, investigate failures and manage deviations, corrective actions, retesting and punch-list closure.
- Prepare the FAT summary and provide a documented technical recommendation on shipment readiness.
Installation and Site Acceptance Testing (SAT)
- Coordinate equipment delivery, installation, utilities, layout interfaces and supplier field support with the site team.
- Confirm installation readiness and alignment with approved technical requirements.
- Develop and lead SAT protocols and test scripts addressing site interfaces, utilities, controls integration and operational performance.
- Verify that equipment performs as intended following shipment, installation and integration.
- Resolve mechanical, process, automation and inspection issues with suppliers and site functions.
- Track outstanding items and provide technical recommendations on readiness for qualification and subsequent project stages.
Qualification and Production Readiness
- Partner with Validation and Quality to align FAT/SAT evidence with the approved qualification strategy.
- Support installation, operational and performance qualification activities, including discrepancy resolution.
- Establish process settings, operating windows and controls for repeatable assembly at production scale.
- Support engineering runs, performance studies, process capability assessments and production ramp-up.
- Contribute to operating procedures, troubleshooting guides, preventive maintenance requirements and operator training.
- Complete technical documentation and facilitate equipment handover to Manufacturing and Engineering.
Project Coordination and Issue Resolution
- Maintain technical action logs, risk registers, decision records and equipment punch lists.
- Communicate progress, critical issues, schedule impacts and recovery actions to project leadership.
- Evaluate supplier changes for effects on requirements, product quality, performance and acceptance testing.
- Coordinate technical decisions with the appropriate client approvers and Quality representatives.
Qualifications:
- Seven+ years of relevant engineering experience in pharmaceutical, biotechnology, medical device or regulated manufacturing.
- Demonstrated experience delivering automated assembly equipment from requirements and design review through FAT, installation and SAT.
- Hands-on experience with injector pens, autoinjectors, cartridge-based delivery systems or comparable precision medical device assembly.
- Experience developing test protocols, leading equipment acceptance testing and resolving supplier/equipment deficiencies.
- Strong understanding of component feeding, precision handling, assembly tolerances, automated inspection and reject systems.
- Ability to interpret engineering drawings, equipment specifications and process performance data.
- Strong technical writing, supplier coordination and cross-functional leadership skills.
Education:
- Bachelor's degree in Mechanical, Industrial, Biomedical, Manufacturing, Chemical or a related engineering discipline.
Equal Opportunity Employer:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.
About RCM:
RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.
Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Senior Process Engineer — Injector Pen Assembly Platform · RCM Technologies, Inc. | Life Sciences / Data & Solutions