Validation Expert
6 days ago
Job Description:
As a Validation Specialist, you will be responsible for ensuring the quality and integrity of our processes and systems. This involves developing, reviewing, and approving validation lifecycle documents, protocols, and reports in accordance with policies, standards, procedures, and guidelines.
You will lead validation activities, provide guidance to junior engineers, and collaborate with multiple functions to plan and ensure smooth qualification activities. Additionally, you will manage stakeholders and facilitate meetings related to validation activities.
Responsibilities include:
- Process RQs (SIP, Bulk Sterilization, Autoclave)
- Warehouse mapping
- Filtration skids
- Trending of Results
- Develop, review, and approve validation lifecycle documents, protocols, and reports
- Lead validation activities and provide guidance to junior engineers
- Review Turnover/Vendor Packages to support qualification activities
- Manage qualification execution and lead deviation investigations
- Collaborate with multiple functions to plan and ensure smooth qualification activities
- Manage stakeholders and facilitate meetings related to validation activities
- Participate in site Validation Maintenance Program
- Support Change Implementation on site
Required Skills and Qualifications:
To be successful in this role, you will need:
- 10+ years of experience in senior role
- 3-5 years of experience in mid-level role
- 0-3 years of experience in junior role
- Strong knowledge of validation principles and practices
- Excellent communication and collaboration skills
Benefits:
This is a full-time position that offers a competitive salary and benefits package.
Other Information:
Seniority level: Mid-Senior level
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