Job Summary:
We are seeking experienced Validation Specialists/ Engineers to join our professional services team at our clients PA location. This team will support our clients continuing validation team in conducting annual requalification activities, including cleaning, sterilization, and Controlled Temperature Unit (CTU) validation. This role requires self-directed professionals capable of performing these essential tasks with general oversight, as our client provides training, equipment, and materials needed to facilitate the validation processes.
Key Responsibilities:
- Independently manage and complete annual requalification activities for client's validation program, including:
- Cleaning validation
- Sterilization validation
- Controlled Temperature Unit (CTU) validation
- Prepare and write comprehensive validation reports following established protocols.
- Coordinate with equipment owners to schedule necessary time and resources to complete validation activities.
- Collaborate with the Clients Validation Department to meet requirement dates and annual workload objectives.
- Manage assigned studies efficiently, contributing to the team's completion of approximately 600+ studies annually.
Qualifications:
- Proven experience in validation activities, including cleaning, sterilization, and CTU processes.
- Ability to work independently with minimal supervision while maintaining a high standard of accuracy and compliance with regulatory requirements.
- Excellent communication and coordination skills to effectively liaise with clients Validation Department and equipment owners.
- Strong time-management abilities to handle the expected workload and maintain consistency across studies.
- Commitment to safety and quality, adhering to Safety First, Quality Always standards.
- Flexibility and dedication to maintain a long-term position, ideally for the full five-year contract period.
