Manufacturing Engineer

3 weeks ago

Thousand Oaks, United States EPITEC Full time

Top 3 skills:

• Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership)

• Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting safety and quality in their area of work.

• Bachelor's degree in engineering or another science-related field with 2+ years of relevant work experience in an operations/manufacturing environment


Day to Day Responsibilities:

• Be individually accountable for the verification deliverables on key capital projects.

• Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.

• Lead, evaluate, and manage the performance of contract resources.

• 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.

• Ensure that validation protocols are executed and documented by cGMP good documentation and safety-compliant practices.

• Ensure safety during commissioning, validation, maintenance, and manufacturing activities.

• Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed.

• Conduct and document periodic equipment validation reviews.

• Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)

• Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.

• Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.

• Provide ad hoc technical support and guidance for manufacturing

• Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification

• Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections

• Participate in internal audits and assess risks in conjunction with QA.

• Assist in developing and maintaining metrics related to equipment performance

• Provide technical expertise to develop reliability improvement plan including design requirements, maintenance strategy, spare part procurement.

• Lead improvement implementation plans while following safety requirements

• Assist with equipment maintenance and troubleshooting during project duration

• Contact vendors as needed to understand and assess any change impact (to equip, utility, facility) as improvements are planned and executed.

• Develop GMP documentation following good documentation practices including validation plans and standard operating procedures.

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