Design & Technology Lead
CSL
full-time
Posted on:
Location Type: Hybrid
Location: King of Prussia • Illinois • Pennsylvania • United States
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Job Level
Tech Stack
About the role
- Design ownership and governance across Tier 1 capital projects ($50M+)
- Provide process technology leadership with a focus on aseptic processing
- Establish and maintain appropriate engineering design standards to ensure consistency across all CapEx projects
- Develop and manage a knowledge management program to ensure all design content is available and understood globally and at site levels
- Lead conceptual and detailed design phases for Tier 1 capital projects, ensuring compliance with cGMP, FDA, EMA, and global standards
- Validate design deliverables against project scope, budget, and schedule
- Develop initial project scope, basis of design, and feasibility assessments
- Collaborate with stakeholders to define user requirements and design criteria
- Execute design assurance reviews and health checks at key project milestones
- Identify risks and implement corrective actions to maintain design integrity
- Provide expert advice to site engineering teams on design standards and best practices
- Mentor site engineers and promote knowledge sharing across global teams
- Engage with external design partners and EPC firms to ensure quality and compliance
- Drive sustainability and modular design strategies in capital projects
- Serve as the global subject matter expert for aseptic processing technologies
Requirements
- Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Chemical, Civil, or related discipline)
- 12+ years in engineering design and process technology for GMP-regulated facilities, with at least 8 years in leadership roles
- Proven track record in Tier 1 capital project design, assurance, and aseptic process technology leadership
- PMP or equivalent; LEED or sustainability certification preferred
- Strong knowledge of biopharma facility design, aseptic processing, clean utilities, HVAC, and process systems
- Familiarity with ISPE Baseline Guides, ASTM E2500, and risk-based design approaches
- Experience with biologics, cell & gene therapy, or sterile manufacturing facilities
- Proficiency in BIM, AutoCAD, and digital design platforms
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
- Bonuses
- Stock options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
engineering designprocess technologyaseptic processingTier 1 capital project designdesign assurancefeasibility assessmentsrisk-based designbiopharma facility designclean utilitiesHVAC
Soft Skills
leadershipmentoringcollaborationknowledge sharingstakeholder engagementproblem-solvingrisk managementcommunicationdesign integritysustainability advocacy
Certifications
PMPLEEDsustainability certification