Engineering Technical Lead Biopharma Project

This opportunity is to join a pharmaceutical manufacturing project in Germany as an Engineering Technical Lead, supporting process scale -up and equipment implementation activities.

The Engineering Technical Lead will provide client -side technical leadership for a pharmaceutical manufacturing project involving process scale -up and will support equipment implementation (led by individual equipment project managers). The role will focus on engineering oversight, technical execution, risk assessment, and high -level commissioning and qualification (CQV) planning for fermentation, process, CIP, and SIP operations for new equipment integration.

The position supports engineering teams responsible for process equipment, utilities, and facility systems and ensures activities align with GMP and regulatory expectations. The role includes responsibility for engineering batches, including the preparation of required documentation such as protocols and reports.

Key Responsibilities

• Support scale -up activities for the complete process
  

• Act as the primary technical reference for engineering decisions and technical issue resolution
  

• Support identification and mitigation of technical and operational risks
  

• Provide oversight for engineering, quality, compliance, and support CQV workflows
  

• Act as the first point of contact for all technical and process -related questions
  

• Define the scope of engineering batch protocols and prepare associated documentation (protocols and reports)
  

• Coordinate day -to -day activities related to engineering batches
  

• Ensure engineering solutions align with scale -up goals, GMP expectations, and industry best practice
  

• Coordinate with engineering, quality, CQV, and operations teams to support execution
  

• Ensure all documentation is prepared in compliance with corporate quality standards
  

Qualifications & Experience

• Degree in Engineering, Science, or a related discipline
  

• 8+ years of experience across the full cGMP project lifecycle within the pharmaceutical or biotech industry
  

• Good understanding of biotechnological processes (yeast preferred)
  

• Strong knowledge of GMP, EU Annex 15, and ISPE guidelines
  

• Experience with utilities, process equipment, and automation systems
  

• Excellent documentation and technical writing skills
  

• Ability to work independently and manage multiple priorities
  

• Fluency in English (German is a plus)
  

Key Competencies

• Strong stakeholder management and communication skills
  

• Detail -oriented with a focus on quality and compliance
  

• Problem -solving mindset with the ability to resolve technical and compliance issues
  

• Proactive and hands -on approach
  

Application Process

Interested candidates are invited to submit their CV and a cover letter outlining relevant experience in pharmaceutical project execution and involvement in process scale -up and equipment integration within regulated environments.

Requirements

Candidates should meet the following criteria:

• A degree in Engineering, Science, or a related discipline
  

• A minimum of 8 years’ experience across the full cGMP project lifecycle within the pharmaceutical or biotechnology industry
  

• Good understanding of biotechnological processes (yeast preferred)
  

• Strong knowledge of GMP, EU Annex 15, and ISPE guidelines
  

• Experience with utilities, process equipment, and automation systems
  

• Excellent documentation and technical writing skills
  

• Ability to work independently and manage multiple priorities
  

• Fluency in English (German is a plus)
  

• Strong stakeholder management and communication skills
  

• Detail -oriented with a focus on quality and compliance
  

• Problem -solving mindset with the ability to resolve technical and compliance issues
  

• Proactive and hands -on approach