For our customer located in Basel/Klybeck/Switzerland we are currently looking for (m/f) a Lead Compliance Engineer
- Type of placement: 12 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
- Salary: level 3, please ask us for the exact rate range
(monthly all in salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k)
Ensures that all engineering relevant processes for investment projects and repair & maintenance are fully cGMP compliant and acts as SPOC for GMP issues in technical/engineering topics in the pilot plant.
- Performs the periodic review of qualified equipment according to the planned intervals and updates the necessary equipment documentation.
- Responsible for the service provider qualification; reviews regularly the performed services within the pilot plant and verifies the qualification status / initiates the qualification process for new service providers.
- Keeps the oversight of all qualified equipment including processes for proper documentation and archiving (life cycle management).
- Prepares / Reviews GxP documents and forms to be used within assigned projects (Risk Assessments, Q Plans and Reports, Release Sheets, Test Sheets, Project Specific SOPs)
- Prepares / Reviews commissioning documents and forms to be used within assigned projects (Commissioning Plan, FAT/SAT Protocols, Test Sheets, Handover Sheets)
- Ensures standardization in the qualification/commissioning process over the different projects in the pilot plant
- Supports and manages the training process for the engineering and its external partners.
- Executes GMP trainings regarding engineering compliance topics for the engineering team and external partners.
- Perform regular quality reviews of the equipment changes; actively manages the Equipment Change Control process from the initiation to closeout ensuring timely execution of the change control process, e.g. following up pending approvals changes, overdue / open changes .
- Prepares GMP Inspections and coordinates follow-ups in the Engineering area.
- Implementation of new/revised guidelines (QM, TGD, SOPs, etc.); execution of gap assessments and owner of corresponding actions.
- Supports Root Cause Analysis for equipment relevant deviations.
- Author/Reviewer and Update of SOPs and FRMs for equipment qualification.
- Technical knowhow in pharmaceutical, chemical and/or infrastructure engineering.
- Extended interdisciplinary technical knowhow.
- Engineering experience in the chemical / pharmaceutical industry.
- IT: Experience MS Office Package, Trackwise (advantageous)
Technical / Professional Knowledge and Skills
- Knowledge in GMP business (extended Knowledge and understanding of all health authority guidelines and best industry practices).
- Technical Knowledge (technical chemical and/or biological knowledge, broad GMP-knowledge, IT-knowledge, continuous improvement).
- Qualification / validation (extended Knowledge in equipment qualification in pharmaceutical industry).
- Interpersonal Skills (good communication skills, coaches and inspires people to achieve team goals; delivers training to maintain state-of-the-art knowledge).
- Safety/Environmental/ cGMP (provides pragmatic solutions to ensure compliance with all regulations).
- Languages: Fluent in German and English.
- Degree in mechanical, process or chemical engineering (Dipl. Ing. Or M.Sc. or B.Sc. or equivalent).
Kindly be informed that this job offer is from our customer in Switzerland. Therefore we can only accept applications within the EU or applicants with Swiss work permissions.
Please attach your CV in Word format.
SimplyVision is looking forward to your application