A services company in Texas is currently seeking a new Validation Engineer for a great opportunity with their team in Austin. In this role, the Validation Engineer will be responsible for supporting validation engineering group by generating validation protocols, executing protocols and leading the review/approval process in a pharmaceutical environment.
Responsibilities:
The Validation Engineer will:

• Be the lead on pharmaceutical validation efforts associated with newly installed or modified equipment, facilities or utilities systems, or revalidation of existing equipment
• Work with change owners to define changes to validated systems and the testing required per plant operating procedures
• Coordinate validation activities with plant operations and other plant supporting functions such as quality testing and instrument calibrations
• Write and review validation protocols, including installation, operational and performance qualifications, using plant procedures and industry standards
• Lead execution of validation protocols and ensure proper documentation of results (good documentation practices)
• Analyze results of testing and implement proper validation activities if results do not meet requirements (i.e., discrepancy generation)
• Perform full, detailed review of validation packages prior to submission for approval
• Write and review validation summary reports
• Maintain schedules of ongoing validation activities

Qualifications:

• 2 years experience in Equipment / Software Validation in a Pharmaceutical environment
• Bachelor's degree in Science or Engineering
• Comfortable and familiar with gowning requirements for cleanroom environment (i.e., some testing and observation to be done in a cleanroom).
• Familiar with cGMPs, FDA and pharmaceutical guidelines
• Familiar with the validation life cycle, and integrated commissioning & qualification approach.
• Great interpersonal skills
• Excellent communication skills (written and verbal)
• Strong attention to detail
• Highly organized