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Project Engineer - CAPEX
Tasks:
Define technical requirements and success criteria, ensuring alignment with GMP standards, operational objectives, and regulatory expectations.
Work closely with stakeholders to incorporate operational improvements into the overall project scope.
Develop and maintain a full project lifecycle roadmap, from concept and design through to performance qualification (PQ)
Serve as the primary technical authority for the project, ensuring all mechanical changes and process improvements meet specified requirements.
Provide technical guidance and hands-on support to production teams during implementation.
Ensure all activities comply with GMP regulations and internal quality standards.
Partner with Quality Assurance to manage change control processes, including drafting, reviewing, and approving Technical Change Requests (TCRs) and Change Records (CRs).
Coordinate closely with operations, maintenance, engineering, and quality teams to enable seamless integration of changes into production.
Act as the main point of contact between production teams and external engineering partners to resolve technical issues and manage deviations.
Track project progress against defined milestones, timelines, and budgets.
Conduct risk assessments and implement mitigation strategies to minimize potential delays or issues.
Provide regular status updates and technical reports to stakeholders.
Lead commissioning and qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Collaborate with validation teams to ensure all changes are properly tested, compliant, and fit for purpose.
Qualification:
Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related discipline.
Minimum of 5 years’ experience in biopharmaceutical manufacturing, with strong exposure to technical project management or operational excellence.
Demonstrated experience in GMP-regulated environments, including change management and equipment/process qualification.
Practical experience in commissioning, qualification, and validation (CQV) activities.
Solid understanding of GMP requirements and biopharmaceutical manufacturing processes.
Strong project management capabilities and familiarity with relevant tools and methodologies.
Excellent analytical and problem-solving skills in dynamic, fast-paced environments.
Strong interpersonal and communication skills, with the ability to collaborate effectively across functions.
Highly organized and detail-oriented, capable of managing multiple priorities simultaneously.
Fluency in English and German is a must
Requirements:
Start: ASAP
Duration: 6 months
Capacity: 5 days per week
Location: Visp
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