Lead Process Engineer (Operations)

Lead Packaging Process Engineer

Packaging process expert required to support new product introductions, technology transfers, continually monitor and improve packaging operations conducted at Packaging Contract Manufacturing Organizations’ (CMO’s).

Responsibilities

• Responsible for the day to day packaging process operations conducted on behalf of our company at packaging CMO’s. Process owner for the manufacturing processes and ensure the manufacturing process operates effectively and efficiently, to ensure excellence in the supply of product to our patient’s
• Work with packaging CMO’s to maintain and publish KPIs that are focused on delivering the most efficient packaging process
• Conduct process engineering investigations in conjunction with CMO and cross functional support teams to ensure root cause is identified and sustainable CAPAs are in place. Develop and implement cost justified process and equipment improvements, identify and eliminate repetitious machine failures, troubleshoot equipment and process issues and implement improvements under change control, improve manufacturing efficiency by analyzing work flow, space requirements and equipment layout, prepare process reports by collecting, analyzing and summarizing information and trends.
• With support, work closely with the CMO team to support ongoing NPI / Technology Transfer projects and production support works as needed, ensure Standard Operating Procedures are continually updated to streamline and optimize the process.
• With support, work with CMO’s to develop and execute validations on new equipment and processes to the manufacturing facility; ensure excellence in the development and deployment of validation elements including URS, FMEA, IQ, OQ, PQ etc.
• Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs, work in conjunction with other departments to ensure production, quality and safety targets are met and drive systems and processes to eliminate customer complaints.

Requirements

• M.S. in Process Engineering, Packaging Science or equivalent 2 years experience in high volume pharmaceutical and/or healthcare packaging (preferred), providing engineering support for new product/process introductions in accordance with EHS and cGMP standards in pharmaceutical or healthcare packaging industry (in alternative, will accept Bachelor’s degree with 7 years of experience)
• Experience working in a validated environment with strong discipline with regard to change control and risk assessment to evaluate existing manufacturing processes and workflows to identify areas that could benefit from changes and improvements.
• Proven problem-solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action and timely close out of investigations and associated CAPA’s
• In-depth knowledge of primary and secondary packaging of pharmaceutical drug products (Tablets/Capsules/Vials/Syringe) with knowledge of global regulatory requirements related to design and control of these processes.
• Strong mechanical capability with hands on experience with equipment, preferably experience in a technical role within a high-volume manufacturing environment
• Must be able to read and interpret complex engineering drawings and have the ability to understand geometrical dimensioning and tolerance’s and associated relationship with materials, product and process design deployed within the packaging design
• Excellent verbal, written communications including technical report and investigation writing aligned with excellent presentations skills and influencing skills
• There is ~20% of domestic / international travel associated with this role

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