Design & Technology Lead — CSL Behring
CHF 94'500 - 143'000
CSL Behring · Bern (BE)
- Location
- Bern
- Contract
- full-time
- Posted
- 11 days ago
SalaryCHF 94'500 - 143'000
Role overview
Position Summary The Technology & Design Lead is responsible for: Design ownership and governance across Tier 1 capital projects ($50M+), ensuring alignment with business objectives, regulatory requirements, and industry best practices.
Provide process technology leadership with a focus on aseptic processing.
The position ensures robust process definition, system ownership, and ongoing manufacturing support for aseptic equipment operations, fostering consistency and innovation in design and technology execution globally.
- Position Summary The Technology & Design Lead is responsible for: Design ownership and governance across Tier 1 capital projects ($50M+), ensuring alignment with business objectives, regulatory requirements, and industry best practices.
- Provide process technology leadership with a focus on aseptic processing.
- Design Element 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.
- 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;
Main responsibilities
- Design Element 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.
Key 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.
Company and context
- Global mindset and ability to work in a matrix organization
Additional details
- Responsibilities Design Element Establish and maintain appropriate engineering design standards to ensure consistency across all CapEx projects.
- Monitor industry trends and regulatory changes, adapting process technology strategies as needed to maintain competitive advantage and compliance.
- Qualifications 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.
Notes and original content
- PMP or equivalent;