Job Description

Position Title: Senior Validation Specialist

Department:Quality Assurance

Reports To:Validation Manager

FLSA:Exempt

Grade:C1

Date:January 23, 2015

Purpose and Scope

Responsible for the development and execution of validation activities including, design, installation, and operational qualification of equipment/utilities/facilities, process validation for all manufacturing processes, lab equipment qualification, and cleaning validation. Writes, executes, or reviews all of the above listed protocols and reports.

Essential Duties & Responsibilities

  • Develops validation strategies for complex validation projects.
  • Develops and implements creative solutions to complex problems.
  • Work with various departments to assign responsibility for protocol generation, execution, and review.
  • Responsible for the change control system for all validated processes and equipment.
  • Write and maintain site and special projects Master Validation Plans.
  • Plans and coordinates the validation activities for projects.
  • Work with Process Development, Engineering, and Maintenance in establishing equipment purchase requirements from the validation perspective.
  • Responsible for the appropriate qualification of equipment, including its controls systems.
  • Validate environmental controlled environments (warehouse, cold/hot chambers, etc), including product cold-chain transportation systems.
  • Validate aseptic equipment (liquid and powder filling equipment, isolator, lyophilizer, autoclave, de-pyrogenation oven, Steam-In-Place, etc.).
  • Validate cleaning processes (manual or automated).
  • Validate manufacturing processes (liquid, semi-solid, solid bulks, filling, labeling, and packaging).
  • Interface regularly with Engineering, Facilities, Regulatory, and Manufacturing personnel.
  • Provide guidance and leadership over engineers who will write and execute protocols, but reporting into other managers.
  • Perform other related duties as assigned.

Knowledge, Skills & Abilities

  • Proficient knowledge with MS Office.
  • Full understanding and knowledge of domestic and international GMP regulations and industry standard for validation activities.
  • Knowledge and experience in writing protocols and procedures.
  • Skilled at utilizing typical validation tools such as Kaye Validator,
  • Excellent oral and written communication skills demonstrated through interactions internally and externally.
  • Effective organization and project management skills.
  • Efficient in report writing and technical writing skills.
  • Effective troubleshooting and problem solving skills.
  • Ability to execute the validation efforts for the company.
  • Ability to manage multiple projects simultaneously.
  • Ability to work both independently and in conjunction with a team.
  • A valid driver’s license and acceptable Motor Vehicle record required.

Education& Experience

  • Bachelor’s degree in Engineering or related field.
  • Seven or more year’s experience in the pharmaceutical industry, with a minimum of 3 years in validation activities.
  • Experience in Statistical Analysis a plus.

Working Conditions

  • Working conditions are normal for an office environment. Work may require occasional weekend and/or evening work.

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