Senior Process Engineer

Company: Shelby American, Inc.
Location: Boston
Posted on: March 24, 2025

Job Description:

DescriptionSr. Process EngineerValSource is currently looking to identify experienced and technically skilled leaders in Process Engineering to support a variety of exciting projects with clients throughout each of our regions in the US. This is a key part of strengthening ValSource's role in front-end Engineering and enabling end-to-end support for our clients.ResponsibilitiesWe are seeking passionate and energetic leaders with initiative to support clients' Process Engineering programs for Pharmaceutical and Biotech GMP Manufacturing facility systems and equipment. Responsibilities include but are not limited to:

• Report to ValSource Regional Process Engineering or Area Manager but operate with independent drive and judgement day-to-day at client site and with staff team to act in the clients' best needs.
• Manage multidisciplinary teams with representatives from Process Engineering, Automation, CQV and others to drive projects through capital management phases from Concept Design, through Detailed Design and Execution.
• Provide clear technical leadership and expertise to lead teams through Safety assessments (PHA, HAZOP and LOPA) and Quality assessments (Development of CIP/SIP strategy, Automation development and GMP Design review).
• Demonstrate strong organization, technical writing and communication skills. Coordinate succinctly and effectively with the management and reporting team to drive clear and timely decision making.
• Manage budgets and costs within proscribed limits.Ensure the thorough completion of the following process-specific activities:

• Vendor collaboration: build productive relationships to deliver complex equipment in a timely manner.
• Listen and translate clients' operational requirements to a hard design; document these needs in User Requirements and Equipment Specifications to onboard a Vendor.
• Review vendor design specifications and submittals to ensure compliance with client requirements and industry best practices in the physical design.
• Ensure clear communication and prioritization of needs for Structural, Civil, HVAC, Electrical & Construction groups.
• Lead FAT execution at Vendor sites, representing the client. Act as facilitator, supervisor and Safety lead ensuring client Safety and Quality standards are upheld.
• Lead and oversee Execution phase for the Process Team with CQV team, ensuring thorough testing of all requirements and demonstration of system functionality.RequirementsThe individual will be a Process Engineering lead at a client site, representing ValSource and the client. We are seeking talented individuals that have demonstrated the following skillset:
  • Minimum of six (6) years of Process Engineering, Manufacturing, Technical support group or equivalent.
  • Bachelor's Degree (or Master's) in Mechanical, Chemical or Electrical Engineering or very closely related Engineering/Science discipline.
  • Knowledge and expertise in the application of engineering standards (i.e. ASME, ISO, NFPA, NIST).
  • Technical expertise in one or multiple of the following Process Engineering fields: Vaccines, Biologics, Single Use Technology, Hygienic design, CIP, Clean Utilities, Automation (DeltaV or PLC) development, Containment, API or Fill Finish.Preferred
    • Experience working with DeltaV or equivalent Automation system.
    • Experience with Pull Planning/Last Planner system for scheduling.
    • Experience providing comprehensive project support, from process design to execution and equipment turnover.Other informationThis is a full-time position with ValSource. As such, we are not considering applications from employment agencies, independent contractors, or third-party vendors.In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.About ValSourceValSource is one of the largest independent Validation Services Company in North America with over 350 Engineering, Commissioning, Qualification and Validation employees. ValSource returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan, discretionary bonus, etc.Equal Employment OpportunityValSource provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran status.
      #J-18808-Ljbffr

Keywords: Shelby American, Inc., Boston , Senior Process Engineer, Engineering , Boston, Massachusetts