Katalyst Healthcares and Life Sciences
Responsibilities:
- Lead development and maintenance of cleaning validation strategy compliant with US FDA requirements.
- Create cleaning cycle development programs for a variety of equipment including process vessels, clean-in place systems, packaging equipment, parts washers, and production facilities.
- Evaluate manufacturing process documents and equipment cleaning procedures for validation purposes.
- Lead investigation and troubleshooting problems which occur during cleaning.
- Responsible for planning and execution of onsite cleaning validation programs.
- Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval.
- Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval.
- Collaborate with other departments to define protocol contents and actions.
- Develop and author change controls for cleaning process or equipment changes.
- Write and execute IQ/OQ/PQ and cycle development protocols including final reports.
- Maintain an up-to-date knowledge of validation requirements, practices, and procedures.
- Write validation plans and risk assessments related to specific projects and facilities.
- Facilitate the development of user requirement specifications and operational SOPs for equipment.
- Lead cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.
- Responsible for identifying appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies.
- Develop, review, and revise standard operating procedures and guidelines for product and equipment cleaning.
- Other duties as assigned.
- Bachelor's Degree or equivalent in a scientific/pharmaceutical area
- 5+ years of cleaning validation or engineering work in GMP and FDA regulated environment.
- Ability to independently generate protocols and reports for evaluation experiments.
- Advanced knowledge of various analytical equipment and techniques utilized in an analytical laboratory.
- Understanding of regulatory requirements related to cleaning validation and cleaning equipment/CIP design.
- Experience in risk management and client service/project management.
- Demonstrated ability to work both independently and in a team environment.
- Familiarity with production equipment and processing technologies.
- Proficient in Microsoft Office programs (Word, Excel, Outlook, CAD) and CRM software.
- Travel up to 10%.
- Knowledge of EU and other global requirements & standards.
- Demonstrated Analytical and Problem-Solving Skills.
- Ability to elicit cooperation from a wide variety of sources, including upper management, customers, suppliers, board, and other departments.
- Excellent written and oral communication skills.
- Ability to lift to 25 pounds.
- Ability to work in a dynamic environment with shift priorities.