Position: Design Verification Lead – Future Pharma Facility (Process & Utilities)
Location: Hybrid (Remote + On-site visits to Indianapolis, IN as needed) – Majority remote with on-site presence as needed for key reviews, inspections, or coordination
Open Positions: 5–6
Duration: 6+ months (possible extension to 12 Months)
Hours per week: 40
Start Date: Aug 18th or 25th
Industry: Pharmaceutical Engineering / CAPEX Projects
Role Summary:
- We are hiring Design Verification Leads (DVLs) to support the front-end design and verification phase for a new pharmaceutical manufacturing site focused on small molecule and peptide production. This is a critical pre-construction role requiring deep technical knowledge, cross-functional collaboration, and strong attention to design compliance and regulatory alignment.
- These hybrid positions will support capital project planning and engineering design verification across process systems, utilities, tank farms, and warehouse infrastructure. Candidates must be self-directed, capable of operating in ambiguity, and have deep experience with early-stage facility development in large-scale pharma environments.
- The DVL should have Expertise in AT LEAST one of these areas: Small Molecules / Peptides / Utilities / Tank Farms / API / Warehouse
- MUST Have been a part of Greenfield or Brownfield Facility projects FROM THE GROUND UP
- MUST HAVE CUB and Peptide purification experience
Key Responsibilities:
- Serve as technical lead and design verification authority for designated scopes (process, utilities, facilities) in support of a greenfield pharma manufacturing site.
- Ensure that design documentation (URS, PFDs, P&IDs, functional specs, layout drawings) accurately reflects GMP requirements and intended process outcomes.
- Drive design reviews and validation activities across disciplines, collaborating with engineering firms, internal project teams, and compliance stakeholders.
- Assess vendor design deliverables and lead gap analyses, ensuring alignment with FDA/EMA regulatory expectations and industry standards.
- Support the development of verification plans and protocols, with a focus on risk-based design qualification and commissioning readiness.
Provide SME-level input into system architecture and layout for:
- Small molecule & peptide manufacturing systems
- Tank farms & fluid handling systems
- Clean and black utilities (WFI, clean steam, HVAC, etc.)
- Warehousing & material handling
- Automation and controls interfaces
- Support project phase transitions from Concept to Basic to Detail Design ensuring traceability and quality throughout the lifecycle.
- Participate in constructability reviews, HSE design checks, and value engineering workshops as needed.
Required Qualifications:
- 15+ years of experience in process engineering, design verification, or facility design in large-scale pharmaceutical projects.
- Proven track record supporting greenfield or major expansion CAPEX programs.
- In-depth knowledge of GMP facility design principles, including ISPE Baseline Guides and ASTM E2500.
Strong experience with:
- Small molecule/peptide process design
- Facility utilities & process support system
- Warehouse and material flow planning
- Large-scale tank systems and fluid distribution
- Familiarity with design documentation tools (e.g., Bluebeam, SmartPlant, AutoCAD, Revit, BIM models).
- Exceptional ability to work cross-functionally with A&E firms, EPCMs, and client-side engineering and QA teams.
- Bachelor’s degree or higher in Engineering (Chemical, Mechanical, or related discipline).
Preferred Qualifications:
- Experience on design teams for Top 20 Big Pharma greenfield sites.
- Background in commissioning, qualification, or startup (CQV) is a strong plus.
- Understanding of digital validation tools and integrated project delivery (IPD) methods.
IN: Design Verification Lead (237950)
#LI-Hybrid