Process Engineer

Description Overview:

Val Source is currently looking to find bright, enthusiastic and experienced leaders in Process Engineering to support exciting GMP Drug Substance and Drug Product capital projects throughout our network. These individuals will be empowered to lead teams and equipment packages, throughout the full project lifecycle—from design and installation through commissioning, qualification, and startup. This is a key part of strengthening Val Source's growing role in front-end Process Design Engineering and enabling end-to-end support for our clients with expert engineers engaged throughout our projects.

Val Source are committed to the development and growth for the hired individual/s to broaden their expertise in unit operations and different areas of Process Engineering.

• Reporting to Val Source's and our client’s Process Engineering Manager, while demonstrating independent drive and sound judgment in day-to-day operations at the client site. The individual will work closely with a mentor Val Source Process Engineer.
• Lead day-to-day tactical vendor coordination: on-site logistics, and field testing.
• Manage multidisciplinary teams with representatives from Process Engineering, Automation, Commissioning, Qualification & Validation (CQV) and others to drive projects through capital management phases from Concept Design, through Detailed Design and Execution.
• Collaborate effectively with client Subject Matter Experts (SMEs) for critical design decisions.
• Demonstrate strong organization, technical writing and communication skills.
• Manage quality, schedule and cost within prescribed project limits.
• Provide clear technical leadership and expertise to lead teams through Safety assessments (PHA, HAZOP and LOPA), Ergonomic and Quality assessments (Development of CIP/SIP strategy, Automation development and GMP Design review). Gather internal and external stakeholder requirements and communicate clear owner's intent, ensure stakeholders are aligned or if not, elevate issues for rapid decision making.
• 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 on site SAT/IOC/IOQ execution at Vendor and client sites. 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.

Serve as Process Engineer and lead scope within the following equipment areas:

• Reactor systems
• Glovebox containment systems
• Potent Charge Isolators systems
• Single use systems
• API equipment (Temperature Control Modules, Analytical Laboratory, Process Collection and Containment equipment)

• Bachelor’s and/or Masters degree in engineering or related field.
• 5+ years of experience in pharmaceutical or biotech manufacturing industry with a preference for experience in capital projects.
• Strong working knowledge of GMP systems, API, potent containment, equipment qualification, and process operations. Field experience troubleshooting equipment is sought after.
• Proven ability to lead teams,…