Staff Packaging & Assembly Engineer

Work Schedule

Environmental Conditions

Job Description

Job 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 teams

• Support the creation and maintenance of product Design Master Records (DMRs) post-submission

Process 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 process

FATs/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 product

Customers:

• 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

Qualifications:

• Graduate level degree (Masters) 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 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.

• 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.