Analytical Engineer

About the job
Location: Thousand Oaks, CA

Duration: 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.).
Related Activities

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.
Preferred Qualifications / Skills / Experience

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.