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Actalent ยท 2 days ago
Validation Engineer
West Greenwich, RI
Full-time
Onsite
Senior Level
5+ years exp
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Responsibilities
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment systems.
Support Lean Transformation and Excellence in Operations process improvement.
Be individually accountable for the verification deliverables on key capital projects.
Advise and coordinate equipment maintenance to ensure proper working order.
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Develop commissioning and function test plan for equipment modifications and acquisition.
Ensure safety during commissioning, validation, maintenance, and manufacturing activities.
Support Manufacturing and QA with Performance Qualification PQ activities if applicable.
Act as a liaison between Engineering and Manufacturing during project planning, execution, and closeout.
Provide coaching and guidance on the CQP process and risk-based approaches to commissioning and verification.
Qualification
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Required
Bachelors degree in chemical or other Engineering fields
6 years' of relevant work experience with 5 years' experience in Biopharmaceutical operations/manufacturing environment
Experience working in a regulated environment e.g. cGMP OSHA EPA etc. and familiarity with GMP quality systems/processes such as change control nonconformances corrective and preventative actions and qualifications/validation
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors chromatography filtration as well as other equipment needed to support these processes such as autoclaves clean in place CIP systems washers clean steam etc
Ability to analyze problems develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses e.g. Root Cause Analysis
Preferred
Bachelors degree in chemical or other Engineering fields
Company
Actalent
Actalent is an engineering and sciences service company.
5,001-10,000 employees
H1B Sponsorship
Actalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (31)
2022 (63)
2021 (20)
Funding
Current Stage
Late StageLeadership Team
Scott Anderson
Chief Financial Officer
Alison Deming Bucek, SPHR, SHRM-SCP
Human Resource Business Partner
Recent News
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