What are the responsibilities and job description for the Sr. Process Engineer position at Pioneer GMP Consulting?
Position Summary
Pioneer GMP Consulting is seeking an experienced Sr. Process Engineer with 3–7 years of biomanufacturing or pharmaceutical engineering experience to support a global drug manufacturer in Massachusetts. This role focuses on equipment reliability, preventive maintenance execution, troubleshooting, and support for validation and operational readiness activities in a cGMP environment.
The ideal candidate brings strong technical problem-solving skills, a solid understanding of manufacturing and analytical systems, and the ability to collaborate across Quality, Supply Chain, Automation, Engineering, and Validation teams to maintain compliant and efficient operations.
Key Responsibilities
- Execute and document preventive maintenance work orders, engineering assessments, and equipment evaluations.
- Diagnose and resolve equipment- and system-related issues across biomanufacturing and analytical operations.
- Review supplier change notifications and assess equivalency of components or replacement parts.
- Provide on-floor support for validation and maintenance protocols, including data collection and execution oversight.
- Update and maintain engineering drawings, specifications, and component lists.
- Conduct audit trail reviews and manage system user access in accordance with site procedures.
- Support deviation investigations, root cause analysis, and CAPA development.
- Participate in daily/weekly operational meetings and rotate through site support responsibilities.
Required Skills & Experience
- 3–7 years of process engineering experience within a cGMP biopharmaceutical, pharmaceutical, or biotechnology environment.
- Strong understanding of engineering fundamentals, equipment troubleshooting, and preventive maintenance programs.
- Proficiency in root cause analysis and data evaluation (e.g., Excel, control charts).
- Ability to read and interpret P&IDs, engineering drawings, and single-use component diagrams.
- Familiarity with systems such as Veeva, Siemens COMOS, IBM Maximo, OSIsoft PI, Trackwise, and Microsoft Office.
- Effective cross-functional communication and collaboration skills.
Qualifications
- Bachelor’s degree in Chemical, Mechanical, Biochemical Engineering, or a related engineering/science discipline.
- Demonstrated experience supporting equipment reliability, process operations, or facility readiness in regulated environments.
- Experience working with validation teams, quality systems, and risk-based assessments.
- Ability to manage individual tasks while contributing to cross-functional project execution.
Preferred Qualifications
- Experience supporting large-scale facility startup, equipment onboarding, or process technology transfer.
- Exposure to bioprocess systems, utilities, or laboratory equipment troubleshooting.
- Experience with digital systems related to asset management, manufacturing data, or document control.
Compensation & Benefits
Competitive hourly/salary rates commensurate with experience. Travel and per diem allowances may apply depending on assignment.
Equal Opportunity Employer
Pioneer GMP Consulting is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected category under applicable law.