Job Summary
We are seeking experienced Design Verification Leads (DVLs) to support a major pharmaceutical manufacturing project. These roles are critical in ensuring that design intent, regulatory expectations, and operational requirements are fully met throughout the project lifecycle. Successful candidates will serve as subject matter experts (SMEs) guiding design reviews, verification activities, and cross‑functional alignment with engineering, quality, and operations.
Process Design Verification Lead (2 positions)
Experience:
- Oral Solid Dosage (OSD) manufacturing expertise (mandatory)
- Spray‑Dried Dispersion (SDD) experience (highly preferred)
- Active Pharmaceutical Ingredient (API) experience may be considered if strong process knowledge is demonstrated
- Deep understanding of process equipment, unit operations, and GMP design principles
- Ability to lead design verification for process flows, equipment specifications, and critical process parameters
Responsibilities:
- Lead process design verification activities across engineering phases
- Review and approve process design documentation, P&IDs, URS, and equipment specifications
- Ensure alignment with OSD/SDD/API manufacturing requirements and regulatory expectations
- Collaborate with process engineering, quality, and operations teams to resolve design gaps
- Support FAT/SAT, commissioning, and qualification readiness
2. Mechanical Non‑Process Design Verification Lead (2 positions)
Experience:
- Mechanical engineering background with pharmaceutical facility experience (OSD not required)
- Strong understanding of non‑process systems: HVAC, utilities, material handling, facility infrastructure, and equipment integration
- Experience verifying mechanical design packages, layouts, and system interfaces
Responsibilities:
- Lead mechanical design verification for non‑process systems and facility elements
- Review mechanical drawings, equipment layouts, utility designs, and integration points
- Ensure compliance with pharma facility standards, safety requirements, and GMP considerations
- Coordinate with architects, mechanical engineers, and construction teams to resolve design issues
- Support commissioning readiness and mechanical system verification
General Qualifications (All DVL Roles)
- 7+ years of relevant experience in pharmaceutical engineering or manufacturing
- Strong understanding of GMP, regulatory expectations, and engineering best practices
- Proven ability to lead cross‑functional technical discussions and drive design alignment
- Excellent communication, documentation, and stakeholder‑management skills
- Ability to work in a fast‑paced, multi‑disciplinary project environment
Consertus is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We welcome applicants from all backgrounds and identities, and we do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, veteran status, or any other protected status.
Job Type: Full-time
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
