Analytical Engineer - Manufacturing Support
Location
Us, 50250 | France
Job description
Analytical Engineer Manufacturing Support
Location: Thousand Oaks CA
Duration: 12 months (Possible extension)
Key Responsibilities:
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Verification Leadership:
- Take individual accountability for verification deliverables on key capital projects.
- Assist in identifying critical quality parameters and process attributes for new equipment or facility modifications.
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Validation Protocol Development:
- Oversee the development of validation protocols in line with CQP and cGMP standards.
- Lead evaluate and manage the performance of contract resources.
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Oversight and Liaison:
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between Engineering Manufacturing and Quality Assurance during project planning execution and closeout.
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Execution and Safety:
- Ensure validation protocols are executed and documented in accordance with cGMP and safety compliant practices.
- Ensure safety during commissioning validation maintenance and manufacturing activities.
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Periodic Reviews and Investigations:
- Conduct and document periodic equipment validation reviews.
- Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone 5Why etc.).
Related Activities:
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Multidisciplinary Collaboration:
- Participate or lead multidisciplinary site teams e.g. Cross Functional Team Root Cause Analysis lead.
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Process Improvement:
- Support Lean Transformation and Excellence in Operations process improvement initiatives.
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Technical Support and Coaching:
- Provide ad hoc technical support and guidance for manufacturing.
- Coach project teams and engineers on the CQP process and riskbased approaches.
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Compliance and Audits:
- Defend equipmentspecific calibration maintenance and validation during regulatory inspections.
- Participate in internal audits and assess risks in conjunction with QA.
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Metrics and Documentation:
- Assist in developing and maintaining metrics related to equipment performance.
- Develop GMP documentation following good documentation practices including validation plans and standard operating procedures.
Preferred Qualifications / Skills / Experience:
- Bachelors degree in engineering or another sciencerelated field.
- 2 years of relevant work experience in operations/manufacturing environment.
- Direct experience with regulated environments (FDA OSHA EPA etc.).
- Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes clean utilities facilities instruments and equipment.
- Experience implementing riskbased verification on major GMP process equipment/automation projects.
- Demonstrated strong communication and technical writing skills.
- Strengths in facilitation collaboration/networking and problemsolving.
- Experience in developing SOPs and delivering training.
- Proven track record of applying process improvement methodologies (PDCA LEAN Six Sigma).
- Availability to support outside regular hours as needed.
DaytoDay Responsibilities:
Support manufacturing activities associated with cGMP equipment and facilities. Lead activities aligned with Commissioning and Qualification Process to ensure the installation and maintenance of new GMP equipment in a validated state. Oversee equipment implementation operation and reliability collaborating with various teams and ensuring compliance with safety and quality standards. Conduct periodic equipment validation reviews troubleshoot issues and actively contribute to process improvement initiatives.
Job tags
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