Technical Project Engineer

ALTEN; Oberwallis; Vor Ort; CHF 120.000 - 190.000; Vollzeit

Zusammenfassung

ALTEN is seeking a seasoned Technical Project Engineer to lead CAPEX projects in a commercial mammalian cell production environment. You will ensure on-time, on-budget delivery with full GMP and CQV compliance, serving as the technical bridge among engineering, QA and production.

Responsibilities include defining technical requirements, roadmaps, and risk mitigation; coordinating cross-functional activities; and overseeing IQ/OQ/PQ commissioning and validation activities to ensure reliable

Qualifikationen

• Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
• Minimum 5+ years in biopharmaceutical manufacturing, with a strong focus on technical project management and operational excellence.
• Extensive experience in CAPEX project management, including budget oversight, timeline management, and stakeholder coordination.
• Hands-on expertise in CQV of equipment and processes in a GMP environment.
• Proven ability to manage GMP-compliant projects, including change control and qualification activities.

Aufgaben

• Define technical requirements, success criteria, and project roadmaps from conceptual design through PQ, ensuring alignment with GMP standards and compliance.
• Develop and execute comprehensive project strategies, integrating operational improvements and coordinating with stakeholders.
• Serve as the primary technical authority for capital projects, guiding mechanical adaptations and operational enhancements.
• Lead GMP change control processes, including preparation, review, and approval of TCRs and CRs with QA teams.
• Act as the central liaison between operations, maintenance, engineering and quality to ensure seamless integration of changes into production.

Kenntnisse

GMP regulations

Biopharmaceutical manufacturing

CAPEX project management

CQV

Change control

MS Project

Agile

Waterfall

Project management

Cross-functional collaboration

Ausbildung

Biochemical Engineering

Mechanical Engineering

Life Sciences

Tools

MS Project

Jobbeschreibung

We are seeking a seasoned Technical Project Engineer to lead the execution of capital investment projects (CAPEX) within a commercial mammalian cell production line.

This role demands deep expertise in biopharmaceutical manufacturing, with a proven track record in project management, GMP compliance, and Commissioning, Qualification, and Validation (CQV).

As the technical and operational bridge between engineering, quality assurance, and production teams, you will ensure that projects are delivered on time, within budget, and in full compliance with regulatory standards.

Key Responsibilities :

Project Leadership & Strategic Planning

• Define technical requirements, success criteria, and project roadmaps from conceptual design through Performance Qualification (PQ), ensuring alignment with GMP standards, operational goals, and compliance expectations.
• Develop and execute comprehensive project strategies, integrating operational improvements and collaborating closely with stakeholders.

Technical Oversight & CAPEX Management

• Serve as the primary technical authority for capital projects, ensuring all mechanical adaptations and operational enhancements meet specifications and deliver intended improvements.
• Provide technical guidance to production teams during the implementation of operational changes.

GMP Compliance & Quality Assurance

• Ensure full compliance with GMP regulations and internal quality standards across all project activities.
• Lead GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs) in collaboration with Quality Assurance teams.

Cross-Functional Coordination

• Act as the central liaison between operations, maintenance, engineering, and quality teams to ensure seamless integration of technical adaptations into production.
• Facilitate clear communication and alignment between production staff and engineering partners to address technical challenges and deviations.
• Monitor project progress, ensuring milestones are achieved on time and within budget.
• Conduct risk assessments and develop mitigation strategies to address potential roadblocks.
• Provide regular updates and technical reports to stakeholders.
• Lead the planning and execution of equipment commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Oversee and coordinate with validation teams to ensure the effectiveness and reliability of implemented changes.

Qualifications & Experience :

• Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
• Minimum 5+ years in biopharmaceutical manufacturing, with a strong focus on technical project management and operational excellence.
• Extensive experience in CAPEX project management, including budget oversight, timeline management, and stakeholder coordination.
• Hands-on expertise in Commissioning, Qualification, and Validation (CQV) of equipment and processes in a GMP environment.
• Proven ability to manage GMP-compliant projects, including change control and qualification activities.

Skills :

• Fluent German is highly preferred – English is required.
• In-depth knowledge of GMP regulations and biopharmaceutical manufacturing processes.
• Proficiency in project management tools and methodologies (e.g., Agile, Waterfall, MS Project).
• Strong problem-solving skills, with the ability to navigate technical challenges in fast-paced environments.
• Excellent communication and interpersonal skills to lead cross-functional teams effectively.
• Detail-oriented with superior organizational skills to manage multiple complex workstreams.