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 SUMMARY

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. Demonstrate good engineering, effective collaboration, partnering and teamwork skills when interacting with internal and external resources. Support review, and approval of the conceptual, basic and detailed design, procurement, installation and start-up for new plants facilities, equipment, utilities and systems. Ensure 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.

JOB DUTIES

• 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.
• Provide engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects/assignments from initial concept to final closeout.
• 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 LSNE assets are well engineered and maintained throughout their lifecycles.
• Assist with the 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.
• Troubleshooting Equipment/system failures, author deviations for unusual operations.
• Demonstrate an in-depth technical knowledge of Facilities, Systems, Utilities and Equipment (FSUE) systems.
• Initiate, lead and execute Facilities, Systems, Utilities and Equipment (FSUE), cost improvement projects. Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.

PROFESSIONAL SKILLS

• 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.

EXPERIENCE

• 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.
• Process control and Instrumentation for facility control systems experience is desired.
• 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.

EDUCATION

• BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
• A minimum of 3 plus years' experience in engineering, facilities clean utilities and/or plant utilities, preferably in the biotechnology, medical device or pharmaceutical industry.

QUALITIES

• Effectively support internal and external relationships, key stakeholders and vendors.
• Strong understanding of team and group dynamics. Contributes to creating a positive and collaborative culture.
• Hands on and agile to working in a fast paced CMO environment.
• Strong Technical writing skills

• Must be able to gown appropriately and lift and/or move up to 50 pounds
• Must be able to successfully prioritize and manage work projects and assignments.

COMMUNICATIONS & CONTACTS

• Interacts with all departmental staff.
• Works closely with Engineering, Manufacturing, MTS, Quality, EH&S, Facilities, and Validation

TRAVEL < 10% or >15%

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Join us and be part of building the bridge between life changing therapies and patients.

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.