Senior Plant Engineer: Biopharma Utilities & Systems

PCI TRGR Penn Pharmaceutical Services Ltd

Bedford (NH)

On-site

USD 95,000 - 120,000

Full time

14 days+

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Job summary

PCI Pharma Services is seeking a Plant Engineer III to provide engineering support across multiple manufacturing facilities, focusing on process equipment improvements, capital projects, and facility upgrades, including water pretreatment, WFI, steam, HVAC and lyophilization.

You will collaborate with cross-functional teams, ensure cGMP and EH&S adherence, lead IQ/OQ/PQ validation, FAT/SAT testing, and documentation from concept to closeout, and manage vendor relations in a fast-paced biopharma

Qualifications

BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
5+ years’ experience in engineering, facilities clean utilities and/or plant utilities, preferably in biotechnology, medical device or pharmaceutical industry.
Strong understanding of technical project management, Good Engineering Practices, reliability, Lean Principles GMP and non-GMP change control, maintaining regulatory compliance.
Experience with aseptic liquid filling of vials, CIP/SIP and Clean Room, lyophilization, aseptic processes, including refrigerated and frozen capabilities a Plus.
Experience with Computerized Maintenance systems (CMMS), AutoCAD, SolidWorks, PLC & SCADA control system.
Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus.
Demonstrated proficiency in basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.
Strong organization, interpersonal, oral and good written communication skills.
Proficiency with MS Word, MS Excel, MS Project, MS Power Point.

Responsibilities

Support safety through personal engagement and promote accountability within the Plant Engineering Department.
Ensure risks to employee health and safety are controlled.
Conduct activities in accordance with cGMP, EH&S, and site quality systems.
Establish and streamline practices around equipment/spec/design/start-up/commissioning & qualification.
Coordinate fabrication, procurement, installation, start-up, and validation activities with IQ/OQ documentation.
Provide engineer support for FSUE execution from concept to final closeout.
Design and execute engineering runs to test equipment or troubleshoot problems.
Partner with contractors on troubleshooting in the manufacturing environment.
Develop system requirements and perform FAT/SAT testing.
Prepare URS, ETOPs, Risk Assessments, Safety Assessments and other engineering docs for FSUE.
Procure new equipment and maintain engineering records (drawings, manuals, inspection reports).
Support start-up and commissioning activities on equipment and GMP facilities.