Senior Process Engineer - Injectables (Med Device) - new job in Remote, US

Job Title: Senior Process Engineer – Injectables/Medical Devices
Job Type: Permanent Full-Time
Location: Remote

We are searching a permanent full-time Senior Process Engineer who will continuously optimize and drive manufacturing efficiencies for currently commercialized products.

There are two key components to this role: 1 - Existing Commercial Products and 2 - New Product Development. The successful candidate will be expected to provide manufacturing input and lead technology transfers, including scale-up, for new products to be developed starting from the clinical phase thru process validation and commercial launch.

Primary areas of pharmaceutical technology associated with this role are compounding/formulation, syringe and vial filling, and medical device assembly, and previous experience in these areas is required.

WHAT YOU GET TO DO:

Responsibilities include, but are not limited to:
1 - Existing Commercial Products

• Identify areas for process optimization to increase batch size capacity, reduce scrap/improve yields, eliminate unnecessary processing steps, and/or streamline manufacturing processes to reduce lead times
• Support root cause investigations associated with process deviations at contract manufacturing and packaging sites
• Assist in generating and implement effective CAPAs
• Develop, review, execute and/or approve manufacturing batch records, engineering study protocols, and validation protocols
• Lead in the design specification, FAT, SAT, and qualification of new processing equipment and similar for equipment modifications
• Collaborate with Quality to ensure that product is delivered reliably to meet FDA and other global standards without any major quality issues, and to resolve any quality issues
• Collaborate with vendors (e.g. contract manufacturer or packager, raw material, or component suppliers) and/or Supply Chain as part of the production/packaging planning, and S&OP processes
• Assess long-term manufacturing capacity vs. long-term forecast to ensure sufficient capacity to support demand and develop/execute capacity expansion plans to address any projected deficiencies
• Ensure that for any contract manufacturers/packagers, appropriate cost structure is in place covering product cost, capital investment and supply logistics

2 - New Product Development

• Provide the technical assessment/capability of any contract manufacturing organizations considered for clinical and/or commercial manufacturing, ensuring sufficient capacity to meet projected demand
• Assist in evaluating products and processes for any in-house manufacturing considerations
• Collaborate closely with R&D to design commercially viable manufacturing processes and packaging solutions
• Lead technical transfer/process scale-up from development to commercial scale and supply Phase III clinical materials
• Lead in the development and execution of process validation protocols
• Lead in the development of engineering protocols for in-house and/or 3rd party manufacturing or packaging
• Work with the Commercial, Business Development, R&D and Regulatory teams to ensure appropriate levels of support for supply to deliver new growth initiatives, including due diligence on merger and acquisition opportunities

WHAT YOU NEED TO HAVE:

• BS Engineering, Chemical Engineering or related discipline
• Minimum of five (5) years experience in the Pharmaceutical/Biotechnology industry (cGMP environment) working in the vial/syringe filling (aseptic and/or terminally sterilized) and medical device assembly spaces, with experience in both preferred
• Ability to travel 40% - 50% of the time – both domestic and international
• Proven technology transfer experience, working with CMC/R&D teams experience
• Demonstrated experience managing complex technical projects, covering both the technical and financial aspects
• Experience with in-house manufacturing and 3rd party CMOs
• Experience working with controlled substances
• Proven track record of delivering high quality work to tight deadlines.

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.