Validation Specialist – FILLED
The Wellington Group has been engaged to find a Validation Specialist with hands-on experience in cleaning validation for a strong, US Brand of FDA regulated consumer products. Ideal candidate will have additional validation experience ranging from commissioning to process development. Put your cleaning validation experience to work in a new job today!
The Validation Specialist will assist with the daily CQV activities of the Validation Department. The Plant Validation Specialist will be responsible for leading the writing, review, design, implementation and administration phases of the various IQ, OQ, PQ and CV protocols. The Plant Validation Specialist will also have the responsibility for critical utilities, USP water systems and software validation. The Validation specialist should also be familiar with applied knowledge of statistical analysis, SPC is ideal.
Duties and Responsibilities:
- Develops and executes engineering studies, validation protocols (/IQ/OQ/PQ) and summary reports for new and legacy equipment
- Takes a leading role in the qualification and validation activities in support of Manufacturing, and Quality Assurance
- Has strong knowledge of cGMP’s, good documentation practices, industry guidelines quality systems for pharmaceuticals
- Ability to work with personnel from Engineering, Manufacturing, Planning, Technical Services and other departments in the company when executing protocols
- Familiar with chemical unit operations, USP water systems, P&ID and isometrics
- Ability to keep project deadlines
- Create, maintain and follow standards, policies and procedures
- Other duties as assigned
The qualified candidate will have:
- BS Degree in Engineering, Science or related discipline, MS Degree is preferred
- 3+ years of experience as a Validation Engineer or Technician
- Must have strong FDA compliance knowledge and experience
- Experience with cleaning validation is required
- Equipment and process validation in addition is ideal
- Experience working with Commissioning, IQ, OQ, and PQ
- CAPA, customer complaints and non-conformity training and experience
- Able to work with manufacturing, engineering, operations and clients
Industry: Validation Engineer, Cleaning Validation, QVC, IQ, OQ, PQ, P&ID, USP Water, Commissioning, Equipment Validation, Validation Master Plan, Pharmaceutical, cGMP, FDA, CAPA
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)