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Company

Original Job Post

ACL Digital · 3 days ago

Senior Process Engineer

Thousand Oaks, CA

Contract

Onsite

Senior Level

7+ years exp

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Hiring Manager

Chiranjeevi Mittkella

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Responsibilities

Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.

Being individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables

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

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

Developing the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).

Overseeing development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.

Recommend, evaluate, and manage performance of contract resources.

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

Acting as a liaison between engineering and quality assurance during project planning, execution, and closeout.

Ensuring that work executed with safety compliant practices and documented in accordance with cGMP good documentation.

Reviewing and approving the commissioning reports, maintenance practices and parts, and driving productivity improvement.

Participating or leading, when required, multidisciplinary site teams, e.g. cross functional team, root cause analysis lead.

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

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

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

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

Participating in internal audits and assessing in conjunction with quality assurance.

Assisting in developing and maintaining business metric performance.

Qualification

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OperationsManufacturingRegulated environmentsCGMP proceduresPharmaceutical productionBiotech productionClean utilitiesFacilitiesInstrumentsRisk-based verificationGMP process equipmentAutomation projectsValidation protocol developmentCombination productMedical device quality systemsProcess equipment knowledgeCell cultureFermentationPurificationFillingPackagingProcess automation knowledgeAutomation infrastructureAutomation technologiesTechnical writingSOPs developmentTraining deliveryProcess improvement methodologiesPDCALEAN

Required

Bachelor's degree in engineering or another science-related field

7+ years of relevant work experience with 5+ years' 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, including validation protocol development and execution

Understanding and awareness of industry/regulatory trends for verification/validation

Experience with combination product / medical device quality systems verification

Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging

Strong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.

Demonstrated strong communication and technical writing skills

Strengths in facilitation and collaboration / networking

Experience in developing SOPs and delivering training

Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)