A Validation Engineer is needed for a global, research-driven pharmaceutical company focused on improving human and animal health in the Athens, GA area. A senior Validation Lead is responsible for independently planning and executing complex qualifications for biopharmaceutical equipment, utilities, and processes while ensuring strict regulatory compliance and audit readiness.
location: Athens, Georgia
job type: Contract
salary: $40 - 45 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Drafts and executes complex validation plans, protocols, and test strategies for critical site equipment with minimal oversight.
- Leads internal and external project teams to resolve quality issues and support technology transfers.
- Performs equipment, facility, utility, and computer system qualifications for biopharmaceutical production.
- Conducts room qualifications and smoke studies in Grade A pharmaceutical environments.
- Provides oversight and support for media fill qualifications.
- Manages requalification and periodic reviews for autoclaves, depyrogenation tunnels, and cold storage.
- Utilizes Ellab data loggers and software for thermal validation and data collection.
- Develops technical specifications including URS, RA, FRS, and DQ for new systems and equipment.
- Trains personnel on quality and validation principles and shares industry best practices across departments.
- Manages the end-to-end lifecycle of change controls, deviations, and CAPAs to ensure on-time closure.
- Ability to plan, schedule, organize, prioritize and coordinate project activities.
- Ability to function in a leadership role and within cross function teams.
- Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems.
- Excellent written and verbal communication skills.
- Excellence in comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles.
- strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks.
- Ability to make decisions regarding the acceptability of product based on documentation provided.
- Bachelors, preferably in a science or engineering related field.
- 6 years GMP validation or similar experience in a GMP manufacturing or similar production environment.
- Minimum of 10 years GMP validation experience in a GMP or regulated manufacturing or similar environment in lieu of a degrees.
- Experience must be inclusive of at least 3 years leading projects.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
