200+ applicants

Company

Original Job Post

ACL Digital · 6 days ago

Process Engineer

Thousand Oaks, CA

Contract

Onsite

Senior Level

7+ years exp

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Hiring Manager

Madhu Shree

Insider Connection @ACL Digital

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Responsibilities

Model leadership behaviors and positive values to create a positive working environment.

Be individually accountable for the consistent equipment performance.

Be accountable for assigned deliverables on key capital projects.

Suggest design modifications to address risks and design in quality and safety.

Provide oversight for verification deliverables developed by outsourced/contract verification staff.

Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout.

Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.

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

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

Support Lean Transformation and Excellence in Operations process improvement.

Provide ad hoc technical support and guidance for manufacturing and maintenance.

Provide coaching and guidance to project teams and engineers using risk-based approaches.

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

Participate in internal audits and assess in conjunction with quality assurance.

Assist in developing and maintaining business metric performance.

Qualification

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Regulated environmentsCGMP proceduresPharmaceutical productionBiotech productionRisk-based verificationValidation protocol developmentProcess equipmentProcess automationTechnical writing skillsProcess improvement methodologiesPDCALEANSix SigmaCommunicationFacilitationCollaborationOperationsManufacturingQuality Systems VerificationSOPsTraining DevelopmentTeam Player

Required

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, including validation protocol development and execution

Process equipment knowledge – basic principles of cell culture, fermentation, purification, filling

Process automation knowledge – fundamental understanding of automation infrastructure

Strong communication and technical writing skills

Strengths in facilitation and collaboration / networking

Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA, LEAN, Six Sigma, etc.)