Sr Process Engineer – Clean Utilities
About The Position
The Process Engineer - Clean Utilities will serve as an owner’s representative to lead and progress client projects and site efforts. This individual will provide operational and technical support to the Design, Construction Management, CQV/Start-up teams and operations for large-scale facility projects within a cGMP environment. They will directly support the clean utilities area and associated equipment systems from design through site construction and start-up. Specific activities include drafting technical documentation, RFP forms, specifications, data sheets, User Requirement Specifications (URS) and test plans for FAT/SAT/CQV. The candidate will assess current manufacturing processes to identify clean utility needs. They will work with cross-functional teams to implement strategies that improve sustainability, productivity, quality, and profitability while reducing costs.
Requirements
- Bachelor’s degree in Engineering (Chemical, Mechanical, or equivalent preferred).
- 3-10 years working in pharmaceutical industry or relevant high purity water/steam systems and process gases experience in another industry.
- Direct hands-on experience with Clean Utilities Systems (RO/WFI/Clean Steam/Process Gases).
- Process Equipment Knowledge for specification of requirements and overall sizing of supporting utilities.
- Understanding of P&IDs, PFDs, and Material/Energy Balances.
- Process Engineering skills and aptitude.
- Proficient in cGMPs and compendial requirements as they relate to Clean Utility Systems.
- Proficiency in using engineering tools and software platforms.
- Flexibility and willingness to work on various projects and tasks, embracing new challenges with enthusiasm.
- Demonstrated ability to work independently and take initiative to drive projects forward.
Nice To Haves
- FE/PE Certification
Responsibilities
- Lead clean utilities initiatives and direct engineering teams in various phases of project development, from concept design to implementation and testing.
- Support incident investigations, due diligence efforts, and corrective action development related to utility systems.
- Work independently but be quick to ask questions and draw upon the best internal, customer, and industry resources to meet customer requirements accurately and efficiently.
- Build and maintain healthy, long term, professional relationships with coworkers, customers, suppliers, and industry partners.
- Maintain excellent composure, especially under pressure.
- Maintain accurate and comprehensive project documentation, including design specifications, test plans, and progress reports.
- Collect, record, transcribe, and analyze data, and document analytical results in clear, well-organized reports.
- Communicate effectively in person and in writing to keep customers, contractors, and project team well informed of pertinent information in a timely manner.
- Assumes responsibility for filling in gaps in customer communication.
- Foster an environment where new ideas are discussed and developed collaboratively.
- Help others overcome resistance to change.
- Be dedicated to creating solutions to customers' problems.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off and company holidays
- Wellness programs and employee assistance resources
- Professional development support
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What This Job Offers
Job Type
Full-time
Career Level
Senior
