Validation Specialist

SNC-Lavalin

Ireland

Ref: NP655-518

Job description / Role

Employment: Full Time

Kentz, a member of the SNC Lavalin Group, is currently recruiting for a Validation Specialist to be based in Clonmel, Ireland.

Responsibilities:
- Generation / execution of System Impact and Critical Aspect Assessment Impact, Pre-move Test documentation, and Commissioning Test packs
- Generation / execution of equipment and/or process validation protocols and reports, including gap analysis of existing protocols against industry standards
- Analysis of test data
- Troubleshoots issues of diverse scope where analysis of data requires evaluation of identifiable factors.
- Provides support or training to client on validation policies and procedures.
- Provides general support to the Validation group to meet department goals and objectives.

Requirements

- Bachelors degree in an engineering or scientific discipline (e.g. chemistry, biochemistry).
- Thorough knowledge of CGMP and regulatory requirements for validation
- Minimum of 5 years relevant work experience which demonstrates knowledge of validation principles, including: validation planning, user requirement and functional specifications, commissioning, IQ, OQ, PQ and process validation.
- Working knowledge of utilities, cleaning validation, and general production systems used in pharmaceutical manufacturing
- Experience qualifying equipment and systems: incubators, autoclaves, clean utilities,...
- Experience with Solid Dose Manufacturing and Packaging Equipment. • Strong working knowledge of statistics and analysis tools.
- Strong word processing and spreadsheet skills, including processing of formulas.
- Excellent verbal and written communication skills, including strong attention to detail regarding documentation is a must.
- Excellent customer service skills.
- Well organized, self-motivated, and able to work both independently and within a team environment.
- Flexible with the proven ability to prioritize and work to deadlines.
- Position demands an individual who is willing to travel.

Key Benefits:
- Be well supported by this top tier engineering and construction organisation.
- Long term rewarding career on offer.
- Excellent salary package with benefits
- On-going professional and personal development
- Gain valuable experience with major resource projects.

About the Company

Founded in 1911, SNC-Lavalin is one of the leading engineering and construction groups in the world and a major player in the ownership of infrastructure. From offices in over 50 countries, SNC-Lavalin\\\\'s employees are proud to build what matters. Our teams provide engineering, procurement construction, completions and commissioning services together with a range of sustaining capital services to clients in our four industry sectors, oil and gas, mining and metallurgy, infrastructure and power. SNC-Lavalin can also combine these services with its financing and operations and maintenance capabilities to provide complete end-to-end project solutions.

SNC-Lavalin maintains exceptionally high standards for health and safety, ethics and compliance and environmental protection, and is committed to delivering quality projects on budget and on schedule to the complete satisfaction of its clients.

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