Plant Engineer III

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 95,000 - 120,000; Full time

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.

Skills

Technical project management

Good Engineering Practices

Reliability

Lean Principles

GMP

Regulatory compliance

Aseptic filling

CIP/SIP

Clean Room

Lyophilization

Refrigerated/Frozen capabilities

CMMS

AutoCAD

SolidWorks

PLC & SCADA

GMP/FDA experience

Biopharma manufacturing

Communication skills

MS Word

MS Excel

MS Project

MS PowerPoint

Teamwork

Fast-paced environment

Technical writing

Education

BS in Chemical, Mechanical, or other Engineering degree

Tools

CMMS

AutoCAD

SolidWorks

PLC & SCADA

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.

Job Description 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 plants 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.
• 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.

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 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 #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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.