Qualification Lead
About the job
- You have a completed degree in engineering, natural sciences, or an equivalent qualification.
- You have several years of experience in qualification or validation in a GMP-regulated environment, ideally in the pharmaceutical industry.
- You have sound knowledge of GxP, quality systems, and regulatory requirements such as EU GMP and the US FDA.
- You have leadership experience in projects or interdisciplinary teams.
- You have very good spoken and written German and English.
- You lead qualification activities in technical projects and are responsible for quality, schedule, and budget within your area.
- You create, review, and approve qualification-related GMP documents such as URS, QP, DQ, IQ, OQ, and change requests.
- You ensure GMP-compliant implementation of all qualification processes within the project team and at external partners.
- You provide subject-matter leadership and efficiently coordinate cross-functional project teams.
- You work closely with QA, engineering, operations, suppliers, and project management to ensure smooth workflows.
- You monitor the progress of qualification activities and provide regular status reports.
- You are responsible for the final handover of all qualification documentation to the life-cycle qualification team.
- Depending on the project and project phase, you work primarily at the customer's project site; some work from home may be possible by agreement.
- You may work on projects in different customer environments and locations.
- Experience in the pharmaceutical industry is ideal.
About the company
BakerHicks provides design, engineering and project delivery services for buildings, industrial facilities and infrastructure across the United Kingdom and Europe. Its multidisciplinary teams combine architecture, civil and structural engineering, building services and process expertise for clients in regulated and technically complex settings. Work spans aviation, rail, power, nuclear, life sciences, manufacturing and public facilities, with services adapted to each project and sector. The company supports projects from planning and design through construction, commissioning, handover and operational management. Founded in 1957, it is headquartered in Warwick, Warwickshire.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Warwick, United Kingdom
Founded
1957
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Simplify's Take
What believers are saying
- Working patterns include flexibility: BakerHicks explicitly offers flexible and hybrid working.
- Leadership development has a formal programme: BakerHicks describes peer training through employee accounts on its experienced-hire page.
- Graduates receive chartership guidance: the Motherwell civil and structural scheme offers tailored mentorship and assessment preparation.
What critics are saying
- Graduate eligibility is restricted: the Motherwell scheme excludes Graduate visa holders and candidates needing future Skilled Worker sponsorship.
- Security clearance affects eligibility: the senior mechanical building-services role requires obtaining and maintaining appropriate clearance.
- Design duties extend onto sites: the senior mechanical building-services role includes site surveys and construction-stage work.
What makes BakerHicks unique
- Design reviews become immersive: BakerHicks uses augmented and virtual reality to explore buildings before construction.
- Asset data survives handover: BakerHicks has a dedicated Asset Information Service covering verification, tagging and registration.
- Carbon analysis starts early: BakerHicks uses CarboniCa to identify design carbon hotspots.
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