Senior Material Excellence Engineer, Site MSAT

Technical Vendor Execution: Author User Requirement Specifications (URS), perform technical reviews of vendor engineering drawings, execute formal material comparability assessments, define critical material attributes, and initiate/close change controls. Operating within a cross-functional and global matrix setting, this role requires strong project management capabilities, regulatory change-control expertise, and deep technical knowledge of pharmaceutical/biotech manufacturing processes related to viral vectors and cell therapies.

Job Title: Senior Material Excellence Engineer, Site MSAT

Location: Raritan, NJ

12+ Months Contract

Position Summary:

The Senior Material Excellence Engineer, Site MSAT will lead global implementation initiatives for the dual sourcing of Lentivirus (LV) materials under Project S.U.R.G.E (Single Use Resiliency & Growth Evolution). This role drives operational reliability, innovation, and sustainability across internal and external global manufacturing facilities. Operating within a cross-functional and global matrix setting, this role requires strong project management capabilities, regulatory change-control expertise, and deep technical knowledge of pharmaceutical/biotech manufacturing processes related to viral vectors and cell therapies.

Key Responsibilities:

• Dual Sourcing & Process Optimization: Identify, scope, and lead dual-sourcing projects for critical single-use and raw materials utilized in lentivirus manufacturing to boost plant reliability and supply security.

• Technical Vendor Execution: Author User Requirement Specifications (URS), perform technical reviews of vendor engineering drawings, execute formal material comparability assessments, define critical material attributes, and initiate/close change controls.

• Project Governance: Build and maintain detailed schedules using MS Project, tracking critical path items, handoffs, key milestones, and high-level deliverables.

• Supply Chain & Manufacturing Alignment: Partner closely with production, supply chain, logistics, and MSAT teams to ensure material changes integrate smoothly without disrupting manufacturing operations.

• Risk Management & Analytics: Conduct structured risk assessments to proactively mitigate supply chain and manufacturing vulnerabilities; develop executive visuals, dashboards, and timeline analytics.

• Cross-Functional Collaboration: Act as the primary technical MSAT liaison across site leadership, global matrix teams, external suppliers, and quality assurance.

Qualifications & Requirements:

• Education: Bachelor's degree in Biotechnology, Biochemistry, Chemical Engineering, or a related life sciences discipline.

• Experience:

  • Minimum 5+ years of hands-on experience in the pharmaceutical or biotechnology sector.

  • At least 3+ years of formal project management experience within a technical/manufacturing setting.

  • Prior experience with lentiviral vectors (LVV), viral manufacturing, single-use technologies (SUT), or cell & gene therapies is strongly preferred.

• Technical & Regulatory Competencies:

  • Solid working knowledge of cGMP guidelines, FDA, and EMA regulatory standards.

  • Experience with change control procedures, URS generation, material characterization, and tech transfers.

  • Background in upstream and downstream biologics manufacturing workflows.

• Tools & Software:

  • Advanced proficiency with MS Project, Excel, and PowerPoint.

  • PMP, CPM, or equivalent project management certification is a plus.

Thanks

Sri Vardhan

vardhans@infobahnsw.com