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.