Validation Lead/Associate III

Responsibilities

• Oversee and execute equipment FAT, SAT, IQ, OQ, and PQ activities
• Provide guidance, support, and leadership to personnel during daily operations
• Represent CQV in internal, client, and regulatory audits
• Develop procedures and support facility equipment qualification and validation programs
• Conduct or coordinate performance qualification execution for new products
• Maintain and generate accurate records, reports, and documentation
• Initiate and drive change controls (CCM)
• Review and approve Master Batch Records, Master Specification Sheets, and Bill of Materials
• Author and approve qualification and validation documents
• Attend Equipment FAT, including international travel as required
• Lead and participate in planned maintenance activities, including HEPA certification and smoke testing

Requirements

• Bachelor’s degree in a science or technical area
• Minimum of 2 years related experience
• Proficiency in Microsoft Word, Excel, and Outlook
• Experience with enterprise software such as JDE, BPLM, Pilgrim, or Trackwise
• Ability to meet Grade C and D gowning requirements
• Ability to work overtime, including nights and weekends

Preferred Qualifications

• 2 years of supervisory experience

Benefits

• Medical and Dental coverage
• 401(k) with company match
• Paid Time Off and Paid Holidays
• Paid Parental Leave
• Education Assistance Program
• Employee Ownership Plan
• Onsite amenities including a workout facility and cafeteria

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market.