Thermo Fisher Scientific · 2 weeks ago
Staff Packaging & Assembly Engineer
Greenville, NC
Full-time
Onsite
Lead/Staff
8+ years expThermo Fisher Scientific is a leading company in the pharmaceutical sector, and they are seeking a Staff Packaging & Assembly Engineer. This role is responsible for developing and maintaining SOPs, ensuring compliance with regulatory standards, optimizing manufacturing processes, and collaborating with vendors.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Ensure all documentation is accurate, up-to-date, and accessible to relevant personnel
Compile and create documentation in accordance with relevant regulatory requirements
Manage all post-submission Design History File (DHF) updates in collaboration with Development device teams
Support the creation and maintenance of product Design Master Records (DMRs) post-submission
Identify and implement process improvements to enhance efficiency, quality, and safety in manufacturing operations
Conduct root cause analysis and implement corrective actions for process deviations
Collaborate with cross-functional teams to optimize production processes and reduce waste
Responble for process characterization and defining the specification(s) for the critical process parameters (CPPs) to be used for the device assembly process
Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to ensure equipment and systems meet specified requirements
Coordinate with vendors and internal teams to address any issues identified during FATs/SATs
Document and report test results, ensuring all acceptance criteria are met
Work closely with vendors to ensure timely projects and training for equipment
Detailed design review for the assembly and manufacture of a product
Support product feasibility assessments
Coordinate all transfer activities from development to operational QC for device testing
Manage qualification and validation activities associated with exhibit, submission and commercial launch batch manufacturing
Conduct feasibility assessments and determine the manufacturing strategy for device projects with the Steriles technologies
Qualification
Required
8+ years of packaging operations experience in a pharmaceutical manufacturing environment
Experience working with Device vendors and OEMS
Knowledge of the regulatory requirements for devices and combination products with the US and EU, including the compilation of Design History Files and Design Master records
Knowledge of Device Quality Management Systems in accordance with ISO13485 and 21CFR820
Experience of managing Device Development Projects, ideally from concept to launch
Understanding of device and drug/device combination regulatory requirements
Understanding of device design and assembly including tool development and manufacturing processes
Experience with process improvement methodologies (e.g., Lean, Six Sigma)
Excellent problem-solving skills and attention to detail
Strong communication and interpersonal skills
Ability to work collaboratively in a team environment
Preferred
Graduate level degree (Master's) in Pharmaceutical Engineering, Chemical Engineering, Physics, or similar field highly preferred
Experience with FATs/SATs and vendor management is highly desirable
Benefits
Annual incentive bonus plan
401K with company match up to 6%
Tuition reimbursement
A range of other employee benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
2026-01-09
Research & Development World
2026-01-09
EIN Presswire
2026-01-07
Company data provided by crunchbase