Process Engineering Consultant; Pharma

This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$83.00/hr - $101.00/hr

• Deep expertise in pharmaceutical process design and technical packages for sterile/biotech facilities
• Proven ability to lead specification, design, supplier selection, and delivery of critical process equipment (e.g., bioreactors, TFF systems, ancillary rooms, material flow)
• Strong knowledge of GMP, GEP, SHE compliance and lifecycle cost considerations
• Experience developing and approving URS, P&IDs, datasheets, and design assurance reports
• Hands‑on involvement in commissioning & qualification (FAT, SAT, DQ, IQ, OQ) and stage‑gate approvals
• Ability to translate customer requirements into engineering deliverables and ensure digital/data readiness
• Skilled in stakeholder engagement and technical governance throughout concept, design, and execution phases
• Strong collaboration and leadership skills to guide project engineering teams and suppliers

Insight Global is looking to hire a Process SME sitting hybrid in Frederick or Gaithersburg, MD. This individual will ultimately be responsible for:

• Provide technical direction and leadership for specification, design, supplier selection, and delivery of critical technical packages in line with AZ requirements.
• Ensure technical governance throughout the project lifecycle.
• Support the receiving AZ organization during start‑up and early operations to meet performance criteria.
• Govern design, specification, performance, and commissioning & qualification of assigned packages while owning and championing operational lifecycle considerations, including material and waste movement, ancillary room and equipment specifications, maintenance and calibration access, and total lifecycle cost versus capital cost.

Other

Key Responsibilities Include:

• Design Support:
  Provide technical input for Concept, Basic, and Detailed Design stages.
• Information Sharing:
  Gather and communicate company processes and technical data to contractors and suppliers.
• Standards & Requirements:
  Define company standards and performance expectations; translate into technical requirements.
• Supplier Assessment:
  Evaluate critical equipment suppliers and recommend selections.
• Handover:
  Ensure complete and accurate handover documentation.
• Design Development:
  Work with contractors to convert company requirements into engineering deliverables.
• Design Assurance:
  Conduct reviews, issue reports, and identify value engineering opportunities.
• Compliance:
  Ensure SHE and GMP requirements are embedded in all design deliverables.
• Stakeholder Engagement:
  Align design with company stakeholder needs and expectations.
• Risk Management:
  
  Participate in SHE risk assessments and implement mitigations.
• Procurement:
  Support strategy, contractor selection, and technical scope definition.
• User Requirement Specification (URS) Ownership:
  Ensure URSs are complete, accurate, and approved on time.
• Equipment Review:
  Validate datasheets, RFPs, and interface alignment; confirm operating parameters for IT/digital twin.
• P&t:
  Support creation of P&IDs for early execution modules.
• Technical Guidance:
  Coach project teams and ensure solutions meet cost and schedule goals.
• Commissioning &
  
  Qualification:
  
  Support C&Q activities; review and approve FAT, SAT, DQ, IQ, and OQ protocols.
• Approvals:
  Authorize equipment release and commissioning per CPDP stage gates.
• Issue Resolution:
  Provide tactical advice during design and execution phases.
• Operational Support:
  Assist with hypercare, process qualification, and establishment batches.
• Continuous Improvement:
  Capture lessons learned and refine CPDP best practices.

Mid‑Senior level

Contract

Pharmaceutical Manufacturing

• Medical insurance
• Vision insurance
• 401(k)