Validation and Calibration Specialist - Pfizer

Summary

The Validation and calibration Specialist will work within the engineering department and perform validation activities associated with new installation projects (Equipment / Facilities / Utilities / Systems) also will be responsible of instrumentation calibration within the production equipment and utilities.

Role Responsibilities

• Run validation project execution DQ/IQ/OQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved.
• Responsible for leading and executing Validation strategies (Validation Plans, Validation Protocols, Validation Reports) for key site Equipment, Systems and Utilities, in line with current regulatory requirements, corporate policies and local site procedures.

• Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems, processes, or equipment.
• Perform special projects as assigned by department manager and performs other duties to support the engineering department.
•  Assist with validation activities performed by outside validation companies, perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards.

• Responsible for executing revalidation activities for Equipment, Systems and Utilities whenever needed and ensuring that a continuous state of validation is maintained for site Equipment, systems and utilities, including providing validation input for any related change controls.
• Investigate deviations which occur and provide solutions or recommendations for changes and/or improvements.
• Understand and extract the needed data from engineering drawings, specification diagrams and maintenance manuals.

• Ensuring all instrumentations are compliant with the site calibration plan, non-routine calibration and fast acting in order to support production and maintaining all calibration documentations up to date.
• work in a safe manner and in compliance with all pfizer EHS policies, standards and procedures

Basic Qualifications
 

• BS in Engineering, Pharmacy or related science and 5 plus years related experience and/or equivalent combination of education and experience

Preferred Qualifications
 

• Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents.
• Ability to read, analyze and interpret common scientific and technical reports, equipment manuals and translate operational limits into protocols acceptance criteria; able to readily identify/report deviations to the department head  in a timely manner.
• Experience in Equipment, HVAC & utility systems would be preferred
• Good working knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects)
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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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