Title: Senior Process Engineer
Industry: Biopharmaceutical
Location: Holly Springs, NC
DSJ Global is partnered with an industry leading Biopharmaceutical client who is looking to add a new Senior Process Engineer to their growing team in Holly Springs, NC. You will be joining the Facilities and Engineering group to partner closely with corporate engineering teams to design, build, commission, and qualify new equipment needed for drug substance production.
What you will do:
- Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.
- Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order.
- Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations.
- Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
- System guidance to identify performance risks and implement risk reduction strategies.
- Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
- Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
What you will bring:
- Bachelor's degree in Chemical or Mechanical Engineering
- 5+ years' experience in Biopharmaceutical operations/manufacturing environment
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/ systems needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
- Collaborative teammate prepared to work in and embrace a team based environment that relies on communication for effective decision-making
- Strong leadership, technical writing, and communication/presentation skills
