Validation Engineer II

Purpose of the Position:

This position will work with Engineering, Facilities, and Validation to validate both equipment and processes. Duties include writing validation and specification documentation, executing commissioning and validation testing, writing customer specific engineering support documents, and supporting the overall engineering documentation program. This role may also include the purchase and implementation of small equipment items less than $2000 (non-capital projects).

Key Job Responsibilities:

• Write, execute, and report qualification and validation protocols

• Assist in preparation and review of all validation documentation including vendor validation documentation (FAT/SAT/IQ/OQ/PQ)

• Work with multi departmental teams to coordinate and perform validation activities

• Support training of personnel on validation topics

• Lead validation deviation investigations

• Assist during design, evaluation and risk assessment of new systems, equipment, facilities, utilities, processes, cleaning, analytical methods and analytical equipment

• Assist during audits where necessary

• Work with customer project teams to produce engineering and validation documentation such as cleaning plans and Materials of Construction reports

Job Knowledge Required:

Bachelor’s degree in a related science or technical area

• Minimum of five years of validation or process engineering experience with strong knowledge and experience in GMP
• Strong interpersonal and communication skills
• Working knowledge of regulatory and industry standards and requirements
• Strong analytical thinking skills and attention to detail

Equal Opportunity Employer