Senior Process Engineer
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Sr. Process Engineer Biomanufacturing & Facilities Support
Location: Massachusetts (On-Site)
Duration: 12-Month Project-Based Contract
Position Summary
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
37 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
Bachelors 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.
Company Industry
Internet Service Providers / Retail Appliances / Electrical and Electronic Equipment
Key Skills
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Tooling
- Statistical Software
- Process Engineering
- cGMP
- Programmable Logic Controllers
- Public Speaking
- Manufacturing
