Validation Specialist

Piper Life Sciences is actively seeking a Validation Specialist to join a global pharmaceutical organization that produces a catalog of therapies for varying disorders. The Validation Specialist will work hands on with instrumentation and associated computerized systems in a pharmaceutical, GMP environment. This is a Monday - Friday position in the Greater Raleigh, NC area.

Responsibilities of the Validation Specialist:

• Initiate risk assessment, gap analysis and deviation management for commissioning or decommissioning of manufacturing equipment and control software.

• Support change controls, validation planning, FMEAs, specs, comissioning, qualification, IT documentation, and process improvments.

• Collaborate with the system owner with evaluating and recommending appropriate user roles for data integrity, writing instrument operation instructions, and setting up PM plans.

• Author GMP risk assessments, user requirements, specifications, validation plans, protocols (IQ, OQ, PQ), addendums, decommissioning plans and other validation deliverables.

Qualifications of the Validation Specialist:

• B.S. or higher in a science or engineering field

• 1 - 5 years of equipment and/or cleaning validation experience

• Understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements

Compensation of the Validation Specialist:

• 100,000 - $120,000
• Full Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays

Keywords:

Validation, qualification, commissioning, laboratory, pharmaceutical, Trackwise, quality operations, FDA, CFR, Annex, GMP, good manufacturing practices, system owner, risk assessment, gap analysis, deviation management, user roles, data integrity, operation instructions, preventative maintenance

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