5 1 Point System Jobs Hiring in Indiana

Required Pharma and Site Expansion experience
Update:
Heavy P&ID experience, work on P&ID design reviews, review P&ID’s line by line.  Ability to describe design verification from start to finish.
Experience with early design process, detail design experience and specific examples around detail design previous work.  Ability to work pre-conceptual design experience is a must.
Must have change control examples and strategies for execution phases of a new site build out from a design perspective.
Previous experience with material flow, personnel flow and warehouse material flow
Must have vendor experience, managing scope and quality expectations and technical alignment.  Align schedules with FAT and SAT testing to ensure specs are in line with site team.
Working examples of early design and detailed design experience
Job description
The Design Verification Lead is responsible for ensuring that all new and modified equipment, systems, utilities, and processes within the new site drug substance manufacturing facility meet their intended design requirements and regulatory expectations. This role oversees design verification activities across engineering, manufacturing, quality, and validation functions to ensure compliant, efficient, and technically sound operations that support clinical and commercial drug substance production.
Key Responsibilities
1. Design Verification Program Leadership

• Develop, implement, and maintain the Design Verification (DV) framework for facility, equipment, automation, and process changes.
• Ensure alignment with GMP, ICH Q8–Q11, FDA, EMA, and ISPE Baseline Guide expectations for biologics manufacturing.
• Author and approve DV plans, protocols, reports, traceability matrices, and risk assessments.
• Serve as a Technical Lead an design verification authority for designated scopes in support of a new site facility build out

2. User Requirements & Functional Specifications

• Lead cross‑functional teams to translate process needs into User Requirements Specifications (URS).
• Ensure all requirements are testable, traceable, and technically feasible.
• Review and challenge vendor Functional Design Specs (FDS), Detailed Design Specs (DDS), and engineering documentation for completeness and compliance.
• Support the development of verification plans and protocols, with a focus on a risk-based design qualification and commissioning plan