To support validation of manufacturing and packaging processes, cleaning processes, and qualification of equipment.
The Validation Associate supports the procedures for validation in an FDA regulated environment
Perform annual product reviews (APRs) of manufactured drug products.
Draft validation protocols for process, cleaning, equipment, and computer systems as needed.
Perform batch record review of manufactured product for release.
Conduct special projects as directed by the Validation Manager.
Participate in creating master validation plan.
Participate in creating validation policy.
Revise and author SOPs as needed.
Revise batch records as needed.
Participate in the effective use of quality systems.
Collaborate with QC labs on method validations and qualification of lab equipment.
Perform any additional projects/tasks assigned by Validation Manager.
Participate in customer and regulatory inspections.
Participate in employee training program.
Perform all other job duties as assigned by Humco management.
Must be safety minded.
Excellent organization and computer use skills (MS. Word, MS Excel).
Must be able to follow instructions and procedures.
Must be able to interpret analytical data.
Must be scientific and safety minded.
A bachelor’s degree is strongly preferred with emphasis in Math, Engineering, Biology, Chemistry, or Physics.
Experience as a validation engineer or previous experience in validation preferred.
This position is approximately 80% clerical. Occasionally will require walking, bending, lifting (possibly up to 40 lbs. or more). Specific vision abilities required by this job include close vision and color recognition.
This position requires occasional working with hazardous and toxic chemicals, dust, and fumes necessitating use of personal protective equipment such as safety glasses, face shields, respirators, fume hoods, etc.
Within 90 days of initial employment, the Validation Associate should be capable of performing duties as described with minimal assistance. Compliance within the guidelines of the company's Corrective Counseling Policy will be required.
Ability to follow instructions and procedures in a timely and safe manner.
Ability to interact with supervisors, co-workers, in a courteous and professional manner. Ability to retain confidential information as confidential.
All employees will follow and uphold policies as set out and signed in HHG Employee Handbook