Senior Validation Specialist
1 day ago
We are seeking a qualified professional to execute qualification and validation activities for a life cycle approach, following validation plans and complying with cGMP and company procedures as part of the design, build, and qualification, including ongoing operations to maintain the validated state.
About the Role- Author, review, execution, and approval of testing protocols and reports. Responsible for project delivery, participate on project teams, vendor inquiries, and the troubleshooting and monitoring of process systems.
- A minimum of 3-5 years' experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT, or engineering function.
- Experienced in the execution of commissioning and qualification/validation of facilities, utilities, equipment, and instruments (e.g., bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
- Experienced in the maintenance of the validated state, requalification/revalidation (CTUs, cleanrooms, clean equipment, etc.).
- Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.
- Experience of equipment vendor package ownership and system design coordination.
- Critical thinking and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively as part of a team.
- Strong analytical and organizational skills.
This is an excellent opportunity for a motivated and experienced professional to join our organization and contribute to the success of our business.
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