Validation Supervisor - Mechanical

Job description

Nombre del sítio: USA - Montana - Hamilton
Fecha de publicación: Jan 19 2024

The Validation Supervisor - Mechanical will be primarily accountable to ensure Mechanical qualifications on the entire site and all GMP systems operate in a fully validated state in partnership with the other Validation disciplines.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

·  Provides technical support for utility systems (including purified water systems, WFI, compressed air systems, HVAC, and clean steam systems); process equipment and systems; and provide input necessary to establish technical standards (technical specifications) in compliance with GMP and GSK requirements. 
·  Develop and implement templates for standard and specific qualifications (IQ/OQ/PQ protocols) for site equipment and systems to comply with validation policies and regulatory compliance requirements. 
·  Define, develop, analyze, and approve specific validation plans or strategies for projects or minor upgrades of site related equipment in their assigned discipline. 
·  Ensure compliance readiness for Level 3 audits, Level 4 inspections and provide adequate support to inspected departments prior to and during the audit process. 
·  Develop skills of validation staff including technical and regulatory expertise to ensure validation support for all GSK Hamilton projects including IQ, OQ, and PQ protocol development and support of execution. 
·  Provide direct technical support to the value streams through the deployment of Subject Matter Experts from the technical team. 
·  As a member of the Local MSAT department, be accountable for the Mechanical validation team results.
·  Ensure personal objectives are aligned with site goals and objectives.
·  Drive continuous improvement, new technology and new ideas into Validation ways of working.​
·  Supervises the Mechanical Validation team ensuring training, competence, and development are being performed at levels sufficient to support site operations.
·  Manage direct reporting employees time off, hiring, performance management, reward and recognition, and all other applicable HR functions.
·  Assure the design and validation of Hamilton facilities meet the current GSK quality standards in addition to US and European regulatory guidelines.
·  Assure all validation documentation (qualification protocols, reports, SOPs and rationale documents) are issued according to current GSK quality standards in addition to US and European regulatory expectations.
·  Recommend solutions and lead discussions with interested parties to gain a consensus on the qualification of the repair or modification plan detailed in Change Control documents.  Provide validation support to the value streams and support functions and participate in the design and specification of new systems and modifications to existing systems to ensure designs comply with current validation standards and are able to be adequately validated and maintained within validated control. Ensure equipment is validated to meet the specific requirements of the process working closely with the process validation team to align strategy.
·  Provide discipline specific IQ, OQ, and PQ protocol development and execution oversight including summary reports and VSRs per approved project schedules. 
·  Provide Tier 2 Technical support for Validation related issues or projects within the Hamilton site.
·  Prepare discipline specific presentations for regulatory agencies regarding the validation program, testing philosophy, rationales, and results.  Provide technical expertise during regulatory audits including presentations by SMEs and ownership of validation policies and testing philosophies.
·  Support Quality Management System (QMS) implementation within respective area of accountability.  In addition, responsible for completing the training on all relevant GQPs, GQMPs and GSOPs.
·  Perform all job responsibilities in compliance with applicable EHS and GMP regulations, standard operating procedures, and industry practice. 

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

·  Bachelor's Degree in biology, engineering, or life sciences
·  5+ years of experience in Validation in the Vaccines, Pharmaceutical or GMP industry.
·  1+ year(s) of experience in management or supervisory role including matrix environments or managing contractors.

Preferred Qualifications:

·  Master's Degree in biology, engineering, or life sciences

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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