Technical Project Manager
Swisslinx Visp, Schweiz Jetzt bewerben Gepostet vor 3 Tagen Befristet Competitive
Job description:
We are seeking a Technical Project Manager to lead capital investment projects in a GMP-regulated mammalian cell production line, driving initiatives from design to qualification.
About the customer:
The client is a leader in the Pharmaceutical industry, renowned for its innovative solutions and commitment to quality in healthcare.
Requirements:
Project Scope and Strategy Development:
* Define project requirements, align with GMP standards, and integrate operational improvements.
* Develop a roadmap covering design through performance qualification (PQ).
Technical Leadership:
* Act as the primary technical contact, ensuring specifications are met.
* Coordinate with EPCM teams and support production staff in operational improvements.
Quality and Compliance Oversight:
* Ensure compliance with GMP regulations and manage change control processes with QA teams.
Cross-Functional Coordination:
* Collaborate with operations, maintenance, engineering, and quality teams to integrate mechanical adaptations and resolve challenges.
Project Execution and Monitoring:
* Track progress, address risks, and deliver regular updates to stakeholders.
Testing and Qualification:
* Lead commissioning, installation (IQ), operational (OQ), and performance qualification (PQ) activities.
Competences:
Education:
* Bachelor's or Master's degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
Experience:
* Minimum of 5 years' experience in biopharmaceutical manufacturing, with a focus on technical project management or operational excellence.
* Proven track record in GMP-compliant projects, including change management and qualification activities.
* Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes.
Skills:
* Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
* Proficiency in project management tools and methodologies.
* Excellent problem-solving skills to manage technical challenges in a fast-paced environment.
* Effective communication and interpersonal skills for coordinating cross-functional teams.
* Detail-oriented with strong organizational skills for managing multiple workstreams.
Compensation benefits:
* Opportunity to contribute to impactful projects within a leading biopharmaceutical organization.
* A collaborative and innovative work environment.
* Professional growth and development opportunities.
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