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.
#J-18808-Ljbffr