Work ScheduleStandard (Mon-Fri)Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionJob Summary: The Staff Packaging & Assembly Engineer will be responsible for developing and maintaining Standard Operating Procedures (SOPs), On-the-Job Training (OJT) documents, and line templates. This role involves ensuring compliance with regulatory standards, optimizing manufacturing processes, and collaborating with vendors. The ideal candidate will have a strong background in pharmaceutical engineering, process improvements, and experience with Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs).Key Responsibilities:Documentation and Compliance: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 teamsSupport the creation and maintenance of product Design Master Records (DMRs) post-submissionProcess Improvement: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 processFATs/SATs: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.Vendor Management:Work closely with vendors to ensure timely projects and training for equipment.Detailed design review for the assembly and manufacture of a productCustomers:Support product feasibility assessments.Coordinate all transfer activities from development to operational QC for device testingManage qualification and validation activities associated with exhibit, submission and commercial launch batch manufacturingConduct feasibility assessments and determine the manufacturing strategy for device projects with the Steriles technologiesQualifications:Graduate level degree (Master''s) in Pharmaceutical Engineering, Chemical Engineering, Physics, or similar field highly preferred.8+ years of packaging operations experience in a pharmaceutical manufacturing environment.Experience working with Device vendors and OEMSKnowledge 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 21CFR820Experience of managing Device Development Projects, ideally from concept to launchUnderstanding of device and drug/device combination regulatory requirementsUnderstanding of device design and assembly including tool development and manufacturing processesExperience 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.Experience with FATs/SATs and vendor management is highly desirable.Working Conditions:This position may require occasional travel to vendor sites and manufacturing facilities.Work in a fast-paced, dynamic environment with changing priorities.We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.