CQV Valiation Engineer

Azzur Group Marietta , PA 17547

Posted 2 months ago

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Our client, a leader in the pharmaceutical industry, is looking to bring on a Sr. CQV Engineer to their dynamic team. The validation engineer will be focused on a new manufacturing skid install requiring utility qualifications, room qualifications, process validation, and cleaning validation.

Responsibilities:

Generates and executes life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes for (re)qualification/(re)verification.
Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
Writes reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
Writes procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments
Performs P&ID Walkdowns. Performs Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.
Supports the resolution of regulatory observations or manufacturing site issues.

Requirements

Bachelors Degree in engineering, science, or similar field.
2-5 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.
Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.
Experience with temperature mapping.

Working knowledge of FDA and cGMP regulations and documentation practices.

Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams.
Ability to define problems, collect data, establish facts and draw valid conclusions.
Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form.

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CQV Validation Engineer

Azzur Group

Posted 2 months ago

VIEW JOBS Our client, a leader in the pharmaceutical industry, is looking to bring on a Sr. CQV Engineer to their dynamic team. The validation engineer will be focused on a new manufacturing skid install requiring utility qualifications, room qualifications, process validation, and cleaning validation.Responsibilities:<ul> <li>Generates and executes life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes for (re)qualification/(re)verification.</li> <li>Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.</li> <li>Writes reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.</li> <li>Writes procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments</li> <li>Performs P&ID Walkdowns. Performs Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.</li> <li>Supports the resolution of regulatory observations or manufacturing site issues.</li> </ul>Requirements<ul> <li>Bachelors Degree in engineering, science, or similar field.</li> <li>2-5 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.</li> <li>Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.</li> <li>Experience with temperature mapping.</li> </ul><ul><li>Working knowledge of FDA and cGMP regulations and documentation practices. </li></ul><ul> <li>Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams. </li> <li>Ability to define problems, collect data, establish facts and draw valid conclusions.</li> <li>Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form.</li> </ul>

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If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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