Responsible for all aspects of process and cleaning validations on any regulated products including pharmaceuticals, OTC products, and Cosmetics, as well as equipment and system qualifications. This position reports to the Quality Systems Manager
Essential Job Functions:
Ø Maintain and ensure compliance to the site master validation plan. Update plan as needed.
Ø Write validation protocols and reports for equipment, process and cleaning validations. Approval of same documents when written by others.
Ø Conduct process and cleaning validations on any regulated products including pharmaceuticals, OTC products and cosmetics.
Ø Conduct all IQ/OQ/PQ qualifications on both new and existing systems such as USP Water System, compressed air etc.
Ø Assist with creating and/or clean-up of SOPs for cGMP and other products.
Ø Conduct validations where extensive engineering may be required.
Ø Collaborate on engineering requirements needed to validate new equipment especially optical or Electronic/Computer controlled equipment under consideration.
Ø A member of the change control review team to assess the impact of changes to validation of equipment processes or systems.
Ø Conduct special engineering/testing activities when requested.
Ø Attend customer meeting/phone meetings when necessary.
Ø Provide advice to supporting departments on cGMP activities and validation.
Ø Review all validation documents such as executed validation activities, validation deviation reports, etc.
Ø Maintain excellent documentation and records for audits and reviews.
Ø Develop standards and templates for KIK Custom products and for specific customers, in regards to validation activities.
Ø Support customer’s audits from a validation perspective.
Ø Monitor and maintain KIK-Gainesville temperature and relative humidity system.
Ø Additional tasks as assigned by management.
Qualifications / Certifications:
Ø BS Degree in Mechanical/Industrial Engineering, Chemistry, Biology or related science is required.
Ø Minimum 3 years’ experience in Pharmaceutical, Medical Devices or Over The Counter (OTC) products formulation and manufacturing is required. Personal Care products may be considered
Ø Prior experience in the application of production and process controls including process validation, process control plans and statistical process control.
Ø Lean/Six Sigma experience is a plus.
- Pay Type Salary
- 2030 Old Candler Rd, Gainesville, GA 30507, USA