The Cleaning Validation Engineer – OTC Drug and Device Products (CVE) shall generate and execute cleaning validation protocols for the facility (walls, floors, racks, etc.) and equipment (production and ancillary). Cleaning validation protocols shall address requirements for control of all OTC Drug and Device Products (30 to 50 formulations), including assessment of impact/risk to product manufacturing processes and patient safety. Prior to execution of cleaning validation protocols, the CVE shall ensure that adequate and validated test methods are in place for verification of cleaning. As appropriate, test method validation shall be conducted in collaboration with an analytical chemist.
After completion of cleaning validation activities, the EVE shall generate cleaning validation reports for the facility (walls, floors, racks, etc.) and equipment (production and ancillary). Cleaning validation reports shall address requirements for control of all OTC Drug and Device Products (30 to 50 formulations). As required, the CVE shall provide procedure(s) relating to the requirements for ongoing qualification/requalification of cleaning for the facility and finished products, including assessment of impact/risk to product manufacturing processes and patient safety.
Essential Duties and Responsibilities
- Assures that cleaning validation protocols and reports comply with United States Food & Drug Administration, Health Canada, ISO, and alternate regulatory and/or notified body requirements per client request.
- Ensures target dates associated with completion of cleaning validation protocols and reports, and procedure updates are met.
- Responds to comments/inquiries provided by SQA management and client with respect to in process cleaning validation protocols/reports and procedures and executes revisions, as required.
- Responsible for following all SQA requirements related to travel arrangements, submission of work/travel hours, and expense report management.
- Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings (as appropriate).
Qualifications Education and/or Experience
- A Bachelor of Science or an advanced degree in a related field of study and 10 or more years of related experience and training.
- Experience interacting with United States Food & Drug Administration and alternate regulatory and/or notified bodies as required.
- Knowledge and skills associated with generation and execution of cleaning validation protocols/reports and procedure generation/revision.
- Experience leading cleaning validation activities is required in collaboration with an analytical chemist and/or designated support staff.
- Understanding of Data Integrity requirements.
- Experience with and understanding of the following regulations and standards: 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR 820, ISO 9001, ISO 13485, ISO 14971, ICH Q9, ICH Q10.
Other Skills and Abilities
- Ability to read, analyze and interpret applicable guidances, regulations and standards.
- Ability to respond to complex inquiries from SQA management or clients. Ability to effectively present information to SQA management or clients.
If interested in this position, please send your resume to Tami Parker at email@example.com, or call 310-802-4415.