Sr Process Engineer - Clean Utilities

Salas O'Brien

$95K — $115K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in Engineering (Chemical, Mechanical, or equivalent preferred).
  • 3-10 years of experience in the pharmaceutical industry or relevant clean utilities systems experience.
  • Hands-on experience with Clean Utilities Systems (RO/WFI/Clean Steam/Process Gases).
  • Knowledge of P&IDs, PFDs, and Material/Energy Balances.
  • Proficient in cGMPs and compendial requirements as they relate to Clean Utility Systems.
  • Adaptable with a willingness to take on various projects and challenges.
  • Demonstrated initiative and ability to work independently.

Responsibilities

  • Lead clean utilities initiatives and direct engineering teams through project phases, from design to testing.
  • Work independently while collaborating and drawing upon internal and external resources to meet customer needs.
  • Maintain accurate project documentation, including specifications and progress reports.
  • Communicate effectively to keep all stakeholders informed timely and fill communication gaps.
  • Foster a collaborative environment where new ideas are discussed and developed.

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
Full Job Description
Job Details

Description

Sr Process Engineer - Clean Utilities

We9re currently accepting applications for Process Engineer candidates to be considered for future projects.

Job Summary: The Process Engineer - Clean Utilities will serve as an owner9s 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.

Responsibilities:
  • Project Support: 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.
  • Collaboration: 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.
  • Documentation: 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.
  • Communication: 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.
  • Innovation: Foster an environment where new ideas are discussed and developed collaboratively. They will help others overcome resistance to change. The candidate will be dedicated to creating solutions to customers9 problems.

Qualifications and Experience:
  • Education: Bachelor9s degree in Engineering (Chemical, Mechanical, or equivalent preferred).
  • Experience: 3-10 years working in pharmaceutical industry or relevant high purity water/steam systems and process gases experience in another industry.
  • Technical Skills:
    • 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.
  • Adaptability: Flexibility and willingness to work on various projects and tasks, embracing new challenges with enthusiasm.
  • Initiative: Demonstrated ability to work independently and take initiative to drive projects forward.
  • Nice to Have:
    • FE/PE Certification

Location: This is not a remote role. This position will be required to report to a client site in Raleigh, NC.

Travel: Flexibility and willingness for occasional travel based on project needs.

Compensation & Benefits:

Actual compensation will be determined based on a number of factors including skills, experience, qualifications, and location. This role is also eligible for performance-based bonuses, and a comprehensive U.S. based benefits package, including:
  • 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

For more information, visit our full benefits overview here.

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