Job Title: Principal Validation Specialist
We are seeking an experienced and skilled Principal Validation Specialist to join our team. The successful candidate will be responsible for ensuring the integrity of our systems, facilities, and equipment.
This is a challenging role that requires strong technical skills, excellent communication abilities, and a passion for quality and compliance. If you have a solid background in validation, commissioning, and qualification, and enjoy working in a dynamic environment, we would love to hear from you.
About the Role
The Principal Validation Specialist will lead and simplify CQV functions, reports, and processes. This includes supporting the implementation of safety programs for major capital projects, commissioning, qualifying, and validating facilities, utilities, and/or equipment in assigned projects.
* Simplify CQV functions, reports, and processes by streamlining workflows and eliminating unnecessary steps.
* Support the implementation of safety programs for major capital projects, ensuring compliance with relevant regulations and standards.
* Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects, ensuring they meet design requirements and industry standards.
* Initiate, author, revise, review, and complete controlled documents for CQV projects, maintaining accurate records and timelines.
* Review and qualify equipment for commissioning, qualification, and validation activities, identifying potential risks and developing mitigation strategies.
* Write and review GMP and GDP documents and technical specifications, ensuring clarity and accuracy.
* Collaborate with multiple departments on assigned project activities and deliverables, fostering effective communication and teamwork.
* Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ, ensuring thorough planning and execution.
* Contact and work with contractors and vendors on assigned projects, managing relationships and expectations.
Requirements
To be successful in this role, you will need:
* A Bachelor's Degree in Engineering or Life Science, with 7-10 years of applicable work experience in the biomedical and pharmaceuticals industry.
* Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents, as well as developing SOPs, final reports, and validation & quality policies.
* Strong experience developing and executing CQV protocols, creating and maintaining CQV policies and processes, and demonstrating strategic thinking and implementation skills.
* Good understanding and compliance with cGMPs and CFR21 Part 11 guidelines, as well as excellent presentation and communication skills, both written and oral, for a variety of audiences.
* Highly organized in planning and time management, with the ability to multi-task and prioritize tasks effectively.