Validation Equipment Specialist
7 days ago
**Job Title:** Validation Equipment Specialist
OverviewTech Tammina is seeking a skilled Validation Equipment Specialist to support the implementation of laboratory and manufacturing equipment at our multi-use sites. This role involves commissioning, qualifying, and maintaining equipment systems in compliance with established policies and procedures.
Responsibilities- Maintain qualified equipment systems in accordance with policies, guidelines, and procedures.
- Develop qualification protocols and reports while adhering to change management processes.
- Execute equipment qualifications and validation protocols for manufacturing and laboratory equipment, utilities, and facilities.
- Temperature map Controlled Temperature Units using wired or wireless mapping systems.
- Supervise vendors for qualification functions.
- Develop validation/qualification deliverables such as IOQ Protocols, Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls.
- Bachelor's degree in Engineering or Science related discipline preferred.
- Minimum 5 years of experience performing/supporting activities in a GMP environment.
- Minimum 3 years of experience in bio/pharmaceutical equipment, facility, or utility qualification.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, and good documentation practices.
- Strong written and verbal communication skills.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Strong multi-tasking ability in conjunction with proven organizational skills.
- Highly proficient computer skills in Microsoft Office Suite Word, Excel, PowerPoint, and Outlook.
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