Senior Process Engineer (CQV)

ValSource 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.

Responsibilities

We 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 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 best practice client and industry standards are translated into 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.
Requirements/Expereince:

The 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 end-to-end project support (from Process Design, through to end of Execution or Equipment Turnover)
Equal Employment Opportunity

ValSource is an equal opportunity employer. We provide 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 status, or veteran status. We are committed to creating an inclusive environment for all employees.

Authorization

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States up hiring/onboarding.  ValSource participates in E-Verify and will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States.

Other Information

These career opportunities are full-time positions with ValSource. Applicants must be authorized to work in the United States on a full-time basis without the need for current or future sponsorship. We do not accept unsolicited applications or resumes from third-party staffing agencies, independent contractors, or recruiting vendors.

About ValSource

ValSource is one of the largest independent validation services companies in North America with over 350 full-time 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 (100% employer paid medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan (ESOP), discretionary bonus, etc.