Project Engineer

Fresenius Kabi; Wilson (NC); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holiday and personal 70

Health benefits: medical, dental, and视

Job summary

Fresenius Kabi in Wilson, NC is seeking a technical professional to lead procurement, design and integration of equipment, process systems and utilities. You will guide the project from initial design studies to final validation, managing schedule and budget while communicating results to stakeholders.

Responsibilities include conducting engineering studies, developing site projects, performing validation (URS, IQ/OQ, FAT/SAT) and coordinating with vendors to ensure compliant, reliable

Qualifications

• Conducts accurate Engineering Studies to develop design space for manufacturing construction, process development, equipment procurement and validation master plan.
• Develops and manages site projects through design, sketches, layouts, vendor interaction, and specifications.
• Executes validation studies (utility, equipment, cleaning, process, computer, new products) with protocol prep, execution and final reports.

Responsibilities

• Conducts accurate Engineering Studies to develop design space, used for manufacturing construction, process development, equipment procurement and validation master plan.
• Develops and manages site projects by employing past experience, research, design and concept sketches, layouts, drawings, vendor interaction, preparation of specifications, discussions with appropriate management and site personnel.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
• Develops and maintains Process Instructions for manufacturing equipment.
• Assists Manufacturing and Maintenance with solving problems, improving processes and reducing costs.

Skills

Engineering Studies

Project Management

Validation Studies

Vendor Interaction

Risk Analysis

Education

Bachelor's degree in Engineering or related field

Tools

URS/HDS/SDS/FRS/IQ/OQ/PQ protocols

Validation Protocols

Job description

Job Summary

This position is responsible for procurement, design and integration of equipment, process systems and corresponding utilities. Leads the project from initial design studies to final validation, and maintains project schedule and budget while communicating results to all stakeholders.

Salary Range: $60,966 - $85,694

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Conducts accurate Engineering Studies to develop design space, used for manufacturing construction, process development, equipment procurement and validation master plan.


• Develops and manages site projects by employing past experience, research, design and concept sketches, layouts, drawings, vendor interaction, preparation of specifications, discussions with appropriate management and site personnel.


• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.


• Develops and executes Engineering Design and Validation protocols (URS, HDS, SDS, FRS, FAT, SAT, DQ, IQ, OQ, PQ)


• Develops and maintains Process Instructions for manufacturing equipment.


• Acts as the primary resource for Cycle Development and Optimization on Aseptic Manufacturing equipment (Sterilizers, Lyophilizes, Automated Decontamination, Parts Washer, CIP/SIP, Formulation, Filling, Depyrogenation, Inspection, Packaging)


• Prepares, writes and executes Risk Analysis (FMEA, Fishbone Diagrams) and Critical Change Requests.


• Prepares funding requests per corporate guidelines, including detailed project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates and schedules.


• Manages and supervises the installation of equipment and/or facility modifications or additions. Includes vendor selection, procurement of equipment or services, scheduling, vendor coordination, rigging, set-up, start-up, troubleshooting, de-bugging, training and budgeting.


• Assists Manufacturing and Maintenance with solving problems, improving processes and reducing costs.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.