Plant Engineer I

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 I 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.

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.
• Under supervision provide engineering support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects/assignments from initial concept to final closeout.
• 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.
• Assist in Preparing URS, ETOPs, Risk Assessments, Safety Assessments and other good engineering documents associated with the Facilities, Systems, Utilities and Equipment (FSUE) as required.
• 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.

• Good organizational ability coupled with strong communication skills, oral and written
• 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.
• Working knowledge of Solid Works, AutoCAD; 3D modeling experience 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. Knowledge of GMPs is essential, but not required as these can be learned on the job.
• Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus.

• BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
• A minimum of 0-2 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.
• Good understanding of team and group dynamics, contributes to creating a positive culture.
• Has capacity for agility to working in a fast paced CMO environment.
• Good Technical writing skills

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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.