Validation Engineer

Position Title: Validation Engineer Department: Validation
Reports To: Validation Supervisor Work Location: Decatur, Illinois

Position Summary:
The validation engineer is responsible for all aspects of the validation process, including documenting commissioning activities, establishing process and equipment acceptance criteria, and developing and performing qualification studies to document evidence that provides a high degree of assurance that equipment and processes (including cleaning processes) will consistently produce a product meeting its predetermined specifications and quality attributes. The Validation Engineer will play an important role at Rising Pharmaceuticals by working closely with all departments and being responsible for various projects, which may include, but are not limited to, the list below.

Essential Duties and Responsibilities:
• Schedule and plan manufacturing, packaging, critical utility, and laboratory equipment IQ, OQ, and PQ and manufacturing process qualification workload to meet the approved schedule.
• Handle multiple projects and work independently.
• Write, execute, and review complex protocols and departmental SOPs.
• Coordinate validation activities with other departments.
• Operate Thermal Mapping equipment, i.e., Kaye in performing temperature mapping on sterilizers, depyrogenation tunnels, lyophilizers, incubators, stability chambers, areas, rooms, etc.
• Write and execute process and cleaning validation protocols.
• Ability to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
• Train other validation personnel.
• Purchase supplies and equipment for validation activities.
• Administer the site change control program.
• Travel to and participate in new equipment FAT’s.

Position Requirements:
Education and Experience:
  • Bachelor of Science Degree in Chemistry, Engineering, Microbiology, or a related field and three (3) years’ experience in the pharmaceutical industry, or equivalent experience
Functional Knowledge:
  • Demonstrated experience validating a wide range of equipment and processes (including cleaning processes), including mixing, sterile fill, freeze drying, parts washers, vial washers, dehydrogenation, wet steam and dry heat sterilization, and packaging.
  • Demonstrate experience and knowledge of qualifying changes to validated systems, processes, and equipment.
  • Excellent conceptualizing, analytical and problem-solving skills
  • Working knowledge of MS Word, Excel, Outlook, and Power Point
Company / Industry related knowledge:
  • cGMP, DEA, and OSHA compliance

Job-Specific Competencies:
• Effective written and oral communication skills
• Strong organizational, planning, and communication skills
• Demonstrates exceptional time management skills
• Using logic and reasoning to identify solutions to problems
• Ability to multi-task, set priorities and meet strict deadlines
• Ability to lead, motivate, coach, and teach others

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