Sr. Validations Specialist

Responsibilities

• Performs the qualification and validation of production equipment, utilities, and computer systems.
• Affords assistance in equipment selection and specification.
• Works on complex problems of broad scope in which analysis of situation or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Maintains all documentation pertaining to qualification and validation.
• Develops procedures, protocols, and validation project plans.
• Serves as Validations resource for contractors and vendors.
• Executes procedures and protocols.
• Maintain the compliance of validated systems through on-going validation activities (e.g., change control, periodic system reviews, etc.).
• Composes/revises SOP’s and master validation plans.
• Collaborate with cross-functional teams to assist in the planning, development, installation, operation, validation, and qualification of newly installed or updated equipment and/or computerized systems.
• Strong knowledge and experience with facility, utility, instrument, and equipment qualifications.
• Ensures completion & compliance with cGMP and all other relevant company training requirements.
• Acts as a certified trainer.
• Provide qualification guidance to IT for infrastructure and computerized system platforms.

Qualifications

• Bachelor’s Degree in Engineering, Chemistry, Biology, or related field required.
• 5+ years of related experience required.
• Excellent knowledge of quality assurance reviews of validations documentation.
• cGMP training and basic understanding.
• Excellent knowledge of pharmaceutical GMP environment.
• Basic knowledge of Kaye AVS.
• Good understanding of and ability to utilize Pro Cal.
• Strong communication skills (oral and written).
• Strong mechanical skills.
• Strong working knowledge of Microsoft Office applications.
• Able to work on multiple projects simultaneously, with strong attention to detail.
• Able to train and mentor others.