About the role
Senior Device Assembly & Packaging Engineer
Position Overview
Brooksource Engineering Services is supporting a leading pharmaceutical manufacturing client that is building a high-volume greenfield drug product facility in Holly Springs, NC. We are seeking a Senior Device Assembly & Packaging Engineer to serve as the technical voice of site operations (User Team). This individual will partner with Project Delivery (CAPEX) teams across the full equipment lifecycle, from OEM selection through operational readiness, with a focus on high-speed autoinjector and pen assembly, labeling, and secondary packaging.
Key Responsibilities
OEM Selection & Design
- Provide input on OEM selection, User Requirement Specifications (URS), design reviews, risk assessments, and related project activities for automated autoinjector and pen assembly and packaging equipment.
- Support equipment integration considerations with site IT/OT systems.
Commissioning & Validation
- Represent the User Team in defining qualification and validation strategies.
- Participate in OEM Factory Acceptance Tests (FATs), installation activities, and commissioning efforts alongside Quality and Validation teams.
Operational Readiness
- Provide input on or lead operational readiness activities, including:
- Standard Operating Procedures (SOPs)
- Maintenance strategies and plans
- Risk management initiatives
- Startup readiness efforts
Cross-Functional Leadership
- Serve as the technical liaison between CAPEX, MSAT, Quality, EHS, Engineering, and Supply Chain teams.
- Train and mentor incoming operations and maintenance personnel.
Qualifications
Education
- B.S., M.S., or Ph.D. in Mechanical Engineering, Automation Engineering, Mechatronics, Biomedical Engineering, or a related technical discipline.
Experience
- 5+ years of experience in pharmaceutical or medical device manufacturing.
- Direct expertise supporting automated autoinjector or multi-dose pen assembly, labeling, and packaging operations.
Project & OEM Execution
- Proven track record leading projects involving multiple OEM vendors from design through implementation, qualification, and technology transfer activities.
- Experience delivering projects within aggressive timelines in a regulated manufacturing environment.
Work Environment
- Up to 20% domestic and international travel for vendor FATs, equipment reviews, and technical benchmarking activities.
- Greenfield construction environment.
- High-speed automated manufacturing and packaging environment.
Client:
Brooksource Engineering Services Pharmaceutical Manufacturing Client.
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