PLANT ENGINEER II/ III

PCI TRGR Penn Pharmaceutical Services Ltd; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services is seeking a Plant Engineer III to provide engineering support across manufacturing areas, driving equipment improvements, process optimization, and capital projects. You will lead start-up, validation, and qualification activities for new and existing facilities, utilities, and systems, while ensuring cGMP adherence and safety standards.

The role requires a strong background in chemical/mechanical engineering, 5–7 years in a similar setting, and proficiency with Lean

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or related engineering field preferred.
• 5–7 years’ experience in engineering in a cGMP environment; equivalent education/experience considered.
• Strong understanding of project management, GMP practices, reliability, and lean principles.

Responsibilities

• Support safety initiatives and promote accountability within Plant Engineering.
• Coordinate design, procurement, installation, and startup for new equipment and systems.
• Lead engineering runs to test equipment and troubleshoot problems.
• Prepare documentation of deviations, CAPAs, and NCs; ensure compliance with EH&S and site quality systems.
• Develop system requirements with end users and validate equipment performance.

Skills

Engineering

Project management

cGMP experience

Lean principles

Communication

Education

Bachelors in Chemical/Mechanical Engineering

Tools

IQ/OQ protocols

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 various manufacturing areas such as process equipment improvements, technological advancements, capital projects, 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 review and approval of the conceptual, basic and detailed design, procurement, installation and start-up for new plants facilities, equipment, utilities and systems. Behaves as a Change Agent to drive innovation and operational effectiveness. 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 initiatives/ opportunities through personal engagement and promote individual accountability for safety within the Plant Engineering Department.
• 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 design, 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.
• Perform process/ equipment investigations and prepare appropriate documentation/ report (deviations, NCs, CAPA).
• 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.
• Execute good Engineering practices for new equipment/Systems/utilities as applicable.
• Procure new equipment, create and maintain the appropriate engineering records including equipment records and manuals, drawings and diagrams, inspection reports per Good Engineering policies.

Qualifications:

• Bachelor’s degree in Chemical, Mechanical, or other related Engineering or scientific discipline preferred
• 5-7 years’ experience in engineering, facilities clean utilities, preferably in a cGMP environment; equivalent combination of education and experience will be considered
• Strong understanding of technical project management, Good Engineering Practices, reliability, and Lean Principles.
• Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus.
• Strong organization, interpersonal, oral and good written communication skills.
• Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharma/medical device processes.
• Proficiency with standard software applications, including Microsoft Office Suite. #LI-AK2

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.