Minimum of 4-5 years of experience of commissioning and validating equipment and field execution. Must have a degree in engineering, science, or similar.
• Knowledge and understanding in developing Validation Master Plans, Validation Protocols, Final Reports, and Performing Studies
• Experienced with facility, utility, equipment, and process validation
• Proficient technical writer with excellent written, verbal communication and interpersonal skills, along with proficiency in MS Office (particularly MS Word and Excel)
• Knowledge and understanding of Pharmaceutical GxPs and excellent cGMP documentation skills
• Ability to communicate with Manufacturing personnel and handle equipment change needs while simultaneously managing multiple projects / priorities
Headquartered in Chicago metropolitan area, Protocol Link is a leading project management and strategy consulting firm providing comprehensive regulatory affairs, cGMP compliance, quality assurance, and validation services to the FDA-regulated companies worldwide. Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment while striving to offer the best of both quality and efficiency. It's how we've been doing business since 1996. The right way.