PLANT ENGINEER I/ II/ III

PCI Pharma Services; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

PCI Pharma Services in Madison, WI is seeking a Plant Engineer II to provide engineering support across manufacturing facilities, driving equipment improvements, capital projects and qualification activities.

You will collaborate with cross-functional teams to ensure safety, quality, and regulatory compliance while delivering reliable facility systems such as water pretreatment, steam, HVAC, and fill finish equipment.

Qualifications

• BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
• Minimum 9+ years' experience in engineering, facilities clean utilities and/or plant utilities.
• Strong understanding of project management, GMP/GxP, 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 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 biopharma/medical device processes.
• Strong organization, interpersonal, oral and good written communication skills.

Responsibilities

• Support safety through personal engagement and promote accountability within the Plant Engineering Department.
• Establish and streamline practices around equipment and/or facility specification, design, start-up, and commissioning; coordinating fabrication, procurement, installation, engineering start-up, and validation activities.
• Provide engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects from concept to closeout.
• Design and execution of engineering runs to test equipment or troubleshoot problems.
• Partner with contractors on troubleshooting assistance for issues found in the manufacturing environment.
• Identify and resolve problems; develop alternative solutions and work in group problem solving.
• Work with end users to develop system requirements and perform Factory/Site Acceptance Testing.
• Prepare URS, ETOPs, Risk Assessments and Safety Assessments for FSUE.
• Execute good Engineering practices for new equipment/Systems/ utilities.
• Coordinate with MTS, Automation, Manufacturing, QA, Facility Operations and Maintenance/Metrology, EHS&S, and Quality Control.

Skills

GMP compliance

Project management

Lean principles

Problem solving

Regulatory affairs

Education

BS in Chemical, Mechanical, or other Engineering degree from an accredited university

Tools

AutoCAD

SolidWorks

PLC & SCADA control system

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 II 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. 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 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 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 9 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.
• 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 MS Word, MS Excel, MS Project, MS Power Point,
• Knowledge of GMP and FDA regulatory requirements for drugs and/or medical devices.

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.