4 Analytical Engineer - Manufacturing Support Jobs in Thousand Oaks, CA
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Analytical Engineer - Manufacturing Support
$92k-109k (estimate)
Contractor
3 Weeks Ago
Zivahh is Hiring an Analytical Engineer - Manufacturing Support Near Thousand Oaks, CA
Location: Thousand Oaks, CADuration: 12 months (Possible extension)Key Responsibilities
- 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.
- 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.
- 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.
- 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.
- Periodic Reviews and Investigations:
- Conduct and document periodic equipment validation reviews.
- Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.).
- Multidisciplinary Collaboration:
- Participate or lead multidisciplinary site teams, e.g., Cross Functional Team, Root Cause Analysis lead.
- Process Improvement:
- Support Lean Transformation and Excellence in Operations process improvement initiatives.
- Technical Support and Coaching:
- Provide ad hoc technical support and guidance for manufacturing.
- Coach project teams and engineers on the CQP process and risk-based approaches.
- Compliance and Audits:
- Defend equipment-specific calibration, maintenance, and validation during regulatory inspections.
- Participate in internal audits and assess risks in conjunction with QA.
- 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.
- Bachelor's degree in engineering or another science-related 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 risk-based verification on major GMP process equipment/automation projects.
- Demonstrated strong communication and technical writing skills.
- Strengths in facilitation, collaboration/networking, and problem-solving.
- 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.
Job Summary
JOB TYPE
Contractor
SALARY
$92k-109k (estimate)
POST DATE
06/05/2024
EXPIRATION DATE
08/18/2024
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