QA Documentation Engineer

Apply now
Job type
Contract
Location
Frankfurt am Main, Hessen, Germany
salary
Competitive
Ref. No
39471
QA Documentation Engineer - Germany, Frankfurt - 12 Months Initial Contract

Looking to take your career to the next level? We’re recruiting for a high-impact pharmaceutical project located near Frankfurt. With major capital investment experience driving various facility build projects. This is a unique opportunity for a QA Documentation Engineer to join a global leader in the life sciences market and play a key role in shaping the future of advanced manufacturing.

What you’ll do:
  • Implement, and maintain document control processes aligned with GMP, GDocP, and project requirements.
  • Support the development and execution of commissioning, qualification, and validation (CQV) documentation.
  • Ensure documentation practices comply with GxP, data integrity (ALCOA ), and internal quality standards.
  • Train project and operational staff on documentation standards, templates, and systems.
What you’ll need:
  • Degree in Life Sciences, Engineering, Quality, or related discipline.
  • Experience in a GMP-regulated biotech, pharmaceutical, or medical device environment.
  • Strong understanding of GDocP, data integrity, and regulatory expectations for documentation.
  • Hands-on experience with document control systems (e.g., Veeva Vault, Kneat, Eida Track Wise,). 
Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!
#LI-KC1

Apply now

Please complete the form for your job application, or feel free to reach out to our consultant directly for assistance.

Contact us

Katarina Chalanska
Senior Principal Delivery Executive
Katarina Chalanska

Jobs you might be interested in

Senior Scientist

ContractDublin, County Dublin, Ireland

Senior Scientist - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Senior Scientist for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Provide technical oversight and ownership of analytical methods. This includes partnering with analytical development to ensure method readiness for validation, assisting with validation protocols, gathering data generated by analytical development/QC labs and assisting with validation reports.Lead complex projects and lead a team of scientists to meet deadlines and collaborate with key stakeholder groups.Provide technical oversight of method revisions.Lead method transfers to QC GMP labs within and outside of the company. What you’ll need: Specific Knowledge, Skills, Abilities, etc:Demonstrated trouble shooting and hands on experience with protein separation methods, for example, CE_SDS or iCIEF Electrophoresis, HPLC and UPLC Chromatography including Size-Exclusion chromatography, ion exchange and UVIS spectroscopy based technologies.Good understanding of the fundamentals of protein characterisation methods such as peptide mapping, and carbohydrate analysis.Experience leading complex projects, projects teams and meeting tight deadlines If this role is of interest, please apply now!#LI-JS4

Utilities SME

ContractDublin, County Dublin, Ireland

Utilities SME - Ireland, Dublin - 12 Month ContractOne of the top 10 best companies to work in Ireland is looking for a Utilities SME for their large-scale new facility in Dublin. Is this you? An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.What you’ll do: Ensuring all the systems are in compliance with all Regulatory requirements including Quality (cGDP/GMP’s), EHS, European directives, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements.Developing Project Requirements Documents (PRD’s) and User Requirements Specs (URS) for new equipment and modifications to existing equipment and systems from concept through supporting installation with the collaboration of stakeholders.Participates in system design reviews, equipment selection & Hazops to ensure the design and Project deliverables meet company requirements, site Engineering specifications and SOP’s.Responsible to evaluate all the drawings and technical data required for Utilities systems to be handed over to the site Engineering doc control for implementation of the project. What you’ll need: The successful candidate must possess a Bachelor/master’s in mechanical engineering discipline.Extensive experience working in pharmaceutical manufacturing facilities in a maintenance engineering or utilities role in a similar scale pharmaceutical manufacturing site with 24x7 operations.Extensive knowledge of Critical Utilities systems in a pharmaceutical facility such as Boilers, steam generation & distribution, chillers, cooling towers, Fire main, Fire Suppression, softened water, RO, WFI, Chemical dosing, WWTP, HVAC, Coldrooms, Freezers, etc.Professional Member of Engineering organisation such as IEI or IET with CEng status or on route to become chartered. If this role is of interest, please apply now!#LI-JS4

Digital Transformation Project Manager

ContractWestport, County Mayo, Ireland

Digital Transformation Project Manager - Ireland, Westport - 12 Month ContractLocated on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Digital Transformation Project Manager to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow. What you’ll do: Coordinate a portfolio of digital transformation projects, liaising with above-site teams and SMEs to represent the Westport site.Collaborate with leadership to develop and implement digital strategies supporting operational and business goals.Collaborate with cross-functional teams, including IT, operations, regulatory affairs, and quality assurance, to gather requirements and ensure alignment of project goals.Drive value analysis and business case development for both new and existing digitisation projects What you’ll need: Bachelor’s degree in Business Administration, Information Technology, Engineering, or a related field.Proven experience in digital transformation and project management, preferably in a manufacturing or biopharmaceutical environment.Experience in Lean, Six Sigma, or other process improvement methodologies.Knowledge of or strong interest in digitisation, technology, and operational excellence principles (e.g., IoT, AI, robotics). If this role is of interest, please apply now!#LI-AJ1