PCI Pharma Services ยท 1 day ago
Plant Engineer III
Bedford, NH
Full-time
Onsite
Senior Level
5+ years expPCI Pharma Services is a company focused on life-changing therapies and global impact. The Plant Engineer III provides engineering support throughout various manufacturing facilities, focusing on process equipment improvements, technological advancements, and safety compliance.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Support safety through personal engagement and promote individual accountability for safety within the Plant Engineering Department. Ensure risks to employee health and safety are rigidly controlled. Conduct all activities in accordance with cGMP, EH&S, and the site quality systems
Establish and streamline practices around equipment and/or facility specification, design, start-up, and commissioning & qualification Coordinating fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems including documentation of IQ/OQ protocols, executions, and summary reports
Provide engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects/assignments from initial concept to final closeout
Design and execution of engineering runs to test equipment or to troubleshoot problems. Design and execution of engineering runs to test equipment or to troubleshoot problems
Partner with contractors on troubleshooting assistance for issues found in the manufacturing environment
Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; Develops alternative solutions; works well in group problem solving situations. provides the technical support for the user with respect to investigations, re-occurring problems, required modifications, optimizations and Continuous Improvements
Work with end users to develop system requirements, specification of equipment/buildings, support fabrication and perform Factory/Site Acceptance Testing
Prepare URS, ETOPs, Risk Assessments, Safety Assessments and other good engineering documents associated with the Facilities, Systems, Utilities and Equipment (FSUE) as required
Execute good Engineering practices for new equipment/Systems/utilities as applicable
Work closely with other support groups such as MTS, Automation, Manufacturing, Quality Assurance, Facility Operations and Maintenance/Metrology, Engineering, EHS&S, and Quality Control to ensure that PCI PHARMA SERVICES assets are well engineered and maintained throughout their lifecycles
Prepare and execute factory acceptance testing (FAT), site acceptance testing (SAT), setup, and commissioning of Facilities, Systems, Utilities and Equipment (FSUE)
Procure new equipment, create and maintain the appropriate engineering records including equipment records and manuals, drawings and diagrams, inspection reports per Good Engineering policies
Support the execution of start-up and commissioning activities on Equipment, utility and GMP manufacturing Facilities, Systems, Utilities and Equipment
Qualification
Required
BS in Chemical, Mechanical, or other Engineering degree from an accredited university
A minimum of 5 plus years' experience in engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device or pharmaceutical industry
Strong understanding of technical project management, Good Engineering Practices, reliability, and 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 filling of vials, and 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 the application of 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 standard software applications, including MS Word, MS Excel, MS Project, MS Power Point
Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices
Effectively support internal and external relationships, key stakeholders and vendors
Excellent understanding of team and group dynamics
Demonstrated agility to working in a fast-paced CMO environment
Excellent technical writing abilities
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase