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Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.
We are searching for Technical Project Managers to support our biotech clients. This role is essential for managing and delivering capital improvement initiatives within our customers’ manufacturing facilities. It combines engineering expertise, operational management, and rigorous project oversight to successfully implement mechanical upgrades and enhance operational efficiency. Serving as the central coordinator, the Technical Project manager connects operations, quality assurance, and external Engineering, Procurement, and Construction Management (EPCM) contractors.
Key Responsibilities:
Technical Direction:
* Serve as the principal technical liaison, validating mechanical upgrades and operational enhancements to ensure adherence to established standards.
* Coordinate closely with EPCM contractors to synchronize engineering deliverables with internal technical and operational expectations.
* Offer technical guidance and mentorship to production teams during implementation phases.
Strategic Project Planning:
* Establish clear technical specifications and performance benchmarks aligned with GMP standards and strategic operational objectives.
* Engage cross-departmentally to identify operational enhancement opportunities and embed them within overall project execution.
* Formulate detailed project timelines and milestone plans, covering initial design through final qualification stages.
Execution and Project Oversight:
* Track project progress against defined technical and operational milestones, maintaining adherence to schedules and budgets.
* Identify, evaluate, and mitigate project risks proactively, ensuring minimal disruption to planned outcomes.
* Prepare and deliver comprehensive progress updates and technical documentation to stakeholders.
Qualification and Validation:
* Direct commissioning processes, installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ) for new and upgraded equipment.
* Coordinate extensively with validation specialists to confirm successful integration and functionality of implemented upgrades.
Quality Assurance and Compliance:
* Oversee project adherence to GMP regulations and internal quality control systems.
* Partner with Quality Assurance to effectively navigate GMP change management, including drafting, reviewing, and authorizing Technical Change Requests (TCRs) and Change Records (CRs).
* Facilitate effective collaboration among operations, maintenance, engineering, and quality teams to seamlessly integrate new mechanical systems into current production workflows.
* Act as a key communication channel between production teams and EPCM providers, proactively addressing technical issues or unexpected project deviations.
Profile Requirements:
Educational Background:
* Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Biotechnology, or equivalent.
Professional Experience:
* Minimum of 8 years' professional experience within biopharmaceutical manufacturing environments, emphasizing technical project oversight or operational process improvement.
* Demonstrated experience managing GMP-regulated projects.
* Hands-on expertise in CQV of equipment and processes within GMP environment.
Key Skills and Competencies:
* Proficient in utilizing established project management methodologies and tools.
* Strong analytical and problem-solving capabilities, especially for navigating technical complexities under tight timelines.
* Exceptional interpersonal and communication skills, essential for facilitating productive cross-functional team collaboration.
* Highly organized and detail-oriented, capable of effectively managing multiple concurrent project streams.
* Languages: fluent French and English (German would be a real asset).
At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!
If you also share the same passion and values, we will be glad to hear from you!
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Engineering and Customer Service
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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