My client is an innovative biotech in the Netherlands, with several high level projects ongoing which require additional support within Engineering. I’m collaborating with them exclusively to find an Interim Automation Lead for 6 months whilst they find a permanent solution.
Key result areas:
- Ensuring all process and building control systems remain operable and reliably maintained
- Oversee new system installations/integrations and existing system modification/upgrades as well as authoring and reviewing any associated support documentation.
- Act as key responsible person for administering CFR 21 Part 11 controls related to Manufacturing and Utility systems including access control, data integrity and audit trail reviews.
- Provides budgetary and schedule estimates for all automation related projects.
- Manager/mentor team within Automation (to be established)
- Review deviations, investigations, and process issues within the company from Automation perspective
- B.S. in Engineering, Computer Science, or related field
- 7+ years’ experience in Biopharma Industry is preferred
- Ability to troubleshoot PLC and SCADA systems. Experience with Allen-Bradley and Johnson Controls is desirable.
- Familiarity with cGMP operations, GAMP5 requirements and CFR 21 Part 11 regulations.
- Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring.
- Able to access crawl spaces and use ladders to access equipment.
Start Date: ASAP (negotiable)
Duration: 6 months (extension possible)
Location: Noord Holland
Process: 1 Stage interview via teams