The Utilities Validation Engineer – OTC Drug and Device Products (UVE) shall generate and execute validation protocols for all facility utilities, including the water system and compressed air. Validation protocols shall address initial (1 month duration) and 6 month (biannual requalification) time points.
After completion of facility utility initial (1 month) validation activities, the UVE shall generate validation reports for each impacted utility, including the water system and compressed air. As required, the UVE shall provide procedure(s) relating to the requirements for ongoing qualification/requalification of utilities (including 6 month biannual requalification).
Essential Duties and Responsibilities
- Assures that utility 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 the utility validation protocols and reports, and procedure updates are met.
- Responds to comments/inquiries provided by SQA management and client with respect to in process utility 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 utility validation protocols/reports and procedure generation/revision.
- Experience leading utility validation activities is required.
- 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.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to use PC’s and associated Microsoft software.
- Balanced technical understanding of products and processes combined with superior business and compliance acumen.
- Accountability, with a strong desire to commit, be held accountable and deliver results.
If interested in this position, please send your resume to Tami Parker at TParker@sqaservices.com, or call 310-802-4415