Manufacturing Process Engineer

Manufacturing Process Engineer

Location:

Bedford, New Hampshire

Department:
Operations

Reporting To:
Manager, Operations

• Support technical activities related to new and existing products, process optimization, process & equipment troubleshooting, and process validation.
• Provide data gathering and analysis as needed to support technical projects and minimize waste and variability in the manufacturing process.
• Maximize the success rate for manufacturing operations by instituting programs to minimize human error, mechanical failure, filling isolator contaminations, procedural errors, and improve yield and efficiency.
• Write standard operational procedures (SOPs), standard test procedures, engineering batch records, and other related GMP documents.
• Assist in training appropriate personnel.
• Troubleshoot process manufacturing equipment, support corrective action initiatives, and collaborate in ensuring utilities and manufacturing equipment meet operating specifications and remain compliant, as required per SOPs and regulatory regulations.
• Maintain a safety‑first approach to manufacturing process development and manufacturing.
• Approve validation protocols or other relevant documents as needed.
• Commission equipment, including all necessary change controls and training, and lead FAT & SAT activities.
• Evaluate and test new equipment and processes, including coordination of outside design, integration, and equipment manufacturing services.
• Research new trends and technologies in advanced aseptic filling/manufacturing.
• Collaborate with appropriate personnel on the development of new manufacturing equipment performance requirements.
• Lead manufacturing investigations and CAPA initiatives as needed.
• Write and execute engineering protocols as needed.
• Perform other duties as assigned by Manager/Supervisor.
• May require overtime and/or weekend work.

• Bachelor's degree in a STEM field (Computer Science, Engineering, Mathematics, Physics, or related discipline).
• Minimum of 3-6 years working in a Pharma cGMP environment; equivalent combination of education and experience will be considered.
• Exposure to parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging equipment preferred.
• Ability to manage teams to execute on‑floor activities such as FAT, SAT, IQ/OQ, and engineering batches.
• Experience in a data‑driven approach to root cause analysis and prioritization of continuous improvement.
• Intermediate/strong computer skills; ability to perform complex computer tasks and use various computer programs to support the operation of the aseptic filling isolator and its relevant equipment/parts.
• Preferred:
  Ability to explain complex technical issues to external customers/agencies.
• Full professional proficiency: ability to speak, read, and write fluently and accurately on all relevant professional levels.
• Very high reasoning ability: ability to define problems, collect data, establish facts, and draw valid conclusions.
• High standard of report writing.

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, equity and inclusion are at the core of our company’s purpose:
Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow.