Plant Engineer III

PCI Pharma Services; Bedford (NH); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Equal Opportunity Employment

Inclusive workplace culture

Job summary

PCI Pharma Services is looking for a Plant Engineer III in Bedford, New Hampshire. This role involves providing engineering support for various manufacturing facilities and ensuring compliance with safety and regulatory standards.

The ideal candidate holds a BS in Engineering and has at least 5 years of relevant experience in the biotechnology or pharmaceutical industry. You will lead critical projects and work closely with functional departments to meet engineering and process requirements.

Qualifications

• Minimum of 5 years' experience in engineering in biotechnology or pharmaceutical industry.
• Experience with aseptic processes including refrigerated and frozen capabilities.
• Knowledge of GMP and FDA regulatory requirements for drugs and medical devices.

Responsibilities

• Support safety through engagement and personal accountability within the Plant Engineering Department.
• Coordinate the engineering start-up and validation of new equipment.
• Provide engineering support for project execution from initial concept to final closeout.

Skills

Technical project management

Good Engineering Practices

Lean Principles

Technical writing

Interpersonal communication

Education

BS in Chemical, Mechanical, or other Engineering

Tools

AutoCAD

SolidWorks

PLC & SCADA control systems

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

The Plant Engineer III provides engineering support throughout the various manufacturing facilities in areas such as process equipment improvements, technological advancements, capital projects, existing manufacturing equipment, cost improvements, facility maintenance, safety and environmental regulation. Demonstrates good engineering, effective collaboration, partnering and teamwork skills when interacting with internal and external resources. Supports the review, and approval of the conceptual, basic and detailed design, procurement, installation and start‑up for new plant facilities, equipment, utilities and systems. Engages with functional department leaders to establish an understanding of the needs/requirements of the department from an equipment capability and capacity perspective. Ensures inclusion of existing site facility and engineering team members in the learning process and design process for new plant systems. Systems include water pretreatment, generation of WFI, plant steam, Clean Steam, Clean Air, Clean Gases, Plant HVAC, Fill Finish equipment and lyophilization. Independently lead Critical and Plant Utility projects from inception to completion.

Essential Duties and 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. Coordinate 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 execute engineering runs to test equipment or to troubleshoot problems.
• Partner with contractors on troubleshooting assistance for issues found in the manufacturing environment.
• Identify and resolve problems in a timely manner; gather and analyze information skillfully; develop alternative solutions; work well in group problem‑solving situations. Provide technical support for users 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, utilities and GMP manufacturing Facilities, Systems, Utilities and Equipment.

Qualifications:

• 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.
• 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.
• 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.

#LI-AK2

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future.

Equal Employment Opportunity (EEO) Statement:

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, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.