Are you interested in leading a team responsible for the validation of equipment and systems at an important drug substance and drug product manufacturing site? Are you interested in delivering innovative technology and building a team to be successful? If so, this Validation Manager role could be an excellent opportunity for you to explore.

*The position has the flexibility to be performed as a Secondment or Full-time opportunity. The Hiring Manager will discuss additional details on options available during the interview process*.

As a Validation Manager, you will be responsible for leading the team responsible for validation of equipment and facilities for the manufacture of biological drug substance and sterile drug product. Validation team responsibilities include the strategy, planning, execution, completion, and maintenance protocols to ensure all processes used in manufacturing and testing remain in a validated state. Fluency in (bio)pharmaceutical processes, facilities, operations, validation methods, and GSK standards in project management, validation, quality, and EHS are essential. Individual management of individual protocols also foreseen.

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

• Lead a team of validation engineers who are individual experts in area specific bioprocess equipment and facility and control system validation. The quality of the validation program has a direct impact on compliance to cGMP's and the ability of the supply chain to gain regulatory approval to manufacture.
• Test and successfully introduce new equipment and processes into the facility - including drug substance unit operations such as buffer preparation, UFDF, mixing, and homogenization and drug product unit operations such as formulation, filling, assembly, and packaging.
• Fluent in quality by design and validation industry standards for equipment and facilities and also innovations in validation execution. Familiar with statutory guidance and GSK standards for above.
• Define and optimize the overall validation strategies, policies, and programs. Strategic planning to include benchmarking against industry trends as well as continuous improvement in the validation program against current compliance standards and regulations.
• Manage the development and execution of validation protocols for all facility services, utilities, equipment, cleaning, maintenance, and systems including computer systems.
• Manage the development, implementation, and maintenance of validation documentation.
• Interface with regulatory inspectors on all validation issues, and present and defend the validation program in regulatory audits.
• Provide validation technical assistance to other GSK organizations when needed. Participate in cross organizational validation discussion and development efforts.
• Interface with Automation, Environmental, Health & Safety, MSAT, Manufacturing, Quality, and Corporate Engineering groups to assure that each project conforms to approved user requirements.
• Guide / mentor / coach team - support their generation of possible solutions and the selection and buy-in of the final solution. Develop high-performing engineers into experienced leaders and experts in manufacturing capable of leading the business outside engineering.
• Ensure EHS corporate standards, local legislation, and other Quality and Regulatory requirements are included while planning and executing all projects. Also, ensure proper identification and assessment of potential EHS risks that are significant to the business and that can be eliminated or minimized before or during project implementation.

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

• Bachelor's degree in engineering or equivalent technical discipline; Mechanical or Chemical Engineering
• 10+ years of pharmaceutical industry validation experience
• Experience leading technical teams.
• Experience with regulatory compliance.

If you have the following characteristics, it would be a plus:

• MBA, master's in engineering, and/or Professional Engineer
• 10+ years of prior project and/or operational validation experience in the pharmaceutical industry is preferred.
• Prior project experience in the design, construction, start-up and operation of large bulk biopharmaceutical drug substance AND drug product fill / finish facilities.
• Familiar with cGMPs, PDA, FDA regulations.
• Detailed understanding of Design, Installation, and Commissioning / Qualification / Validation of new pharmaceutical equipment and/or utilities.
• Must be able to interact well with peers, subordinates, and senior personnel in scientific, engineering, and operational disciplines.
• Demonstrated ability to participate as a leader or member on cross-functional and self-directed work teams.
• Must be comfortable and thrive in ambiguity and think strategically to solve complex problems.
• Sense of Urgency / Decision making.
• Strong interpersonal skills.
• Must be able to work within a multi-disciplinary team environment.
• Must be able to generate options to resolve problems, prioritize solutions and implement decisions.
• Must be competent in handling simultaneously occurring tasks and have excellent written and oral communication skills.

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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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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