Senior Process Engineer

Manufacturing Process Engineer

Sanford, NC

Pay Rate- 65-75/hr

Hunter International is currently seeking a Process Engineer to join their team in Sanford, NC. The Manufacturing Process Engineer will be knowledgeable of process equipment and systems, manufacturing operations, and automation control and provide direct production support during processing operations. Services include review of process requirements and evaluation of equipment and systems to ensure deliverables meet or exceed process specifications and manufacturing requirements. The incumbent will assist with production planning and provide / support coordinating production activities working with the Manufacturing Area Leads. The incumbent will provide technical guidance and systems and automation training to production colleagues. The position of Manufacturing Process Engineer requires direct

production support on rotating shifts as determined by the manufacturing processes and schedules.

The incumbent provides process engineering support of cGMP clinical and /or commercial manufacturing processes and equipment

Manufacturing Process Engineer Responsibilities

• Primary point of contact for operator support and issue resolution
• Responsible for problem diagnosis / root cause(s) determination (automation, mechanical, documentation, training, etc)
• Coordinate activities with PCS to resolve automation issues and changes
• Coordinate activities with maintenance to resolve mechanical issues
• SME of process, equipment, and automation change requests for prioritization.
• Works with PCS to develop detailed automation design(s) and specifications
• Coordinates activities necessary to test and qualify equipment and automation changes in the production environment
• Uses scientific and OE tools/techniques to identify areas to optimize yield and/or and improve efficiencies
• Works with Tech Services, Engineering, Automation, QA, etc to ensure robust manufacturing processes: Contribute to P&IDs, PFDs and process descriptions, Translate process descriptions instructions to meet production equipment / system capabilities, Review and contribute to applicable documentation (i.e. MBRs, SOPs, etc), Ensure equipment requirements can meet processing needs, Review P&IDs and provide support as needed, Per guidance from Tech Services establish process parameters, timers, run rates, material flow, etc as needed, Determine area/equipment interlocks, Establish equipment synchronization requirements,
• Participates in process operational improvements
• Write and/or support formal manufacturing investigations
• Conduct formal written risk assessment
• Review and revise cGMP documents
• Participate and lead change control
• Interaction with internal support groups/customers and external customers examples are equipment vendors/suppliers

Manufacturing Process Engineer Qualifications

• Bachelors degree in engineering. Masters degree preferred.
• At least 8 years of experience in a similar role.
• Specific experience with Purification processes preferred.
• FDA regulated industry required.
• Capable of sitting and/or standing for extended periods of time during the work shift. Must be able to work a rotating shift schedule to support a 24/7 manufacturing operation.

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