Automation Validation Engineer
We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody and small molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us! Click to know more about GSK Biopharm. #GSKBiopharm_Development The Automation Validation Engineer position will establish and maintain the validated state of Direct Impact systems and equipment. This Automation Validation Engineer will also provide validation support for manufacturing teams. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following Leadership in establishing and maintaining the validated state of Direct Impact systems and equipment, with an emphasis on enterprise, / automation systems and Analytical Equipment. Provide validation lifecycle support for manufacturing execution system (MES) e.g. electronic batch record system / equipment tracking system/log book. Management of the validation tasks, deliverables, budgets, and resources associated with capital projects that involve installation of new Direct Impact systems and equipment, with an emphasis on enterprise, automation and analytical systems. Continuous improvement of the effectiveness of local procedures and protocols for maintaining compliance with corporate procedures and policies, as well as with relevant government regulations for GSK markets, in a manner seeking opportunities for risk-based approaches. Serve as the principal validation member and/or Lead on project teams. Lead Matrix teams of subject matter experts to delivering validation project expectations. Participate in development of requirements and specifications. Why you? Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelors degree in a science displace with at least 5
years experience developing technical knowledge of enterprise, laboratory, and manufacturing systems such as LIMS, MES/ electronic batch / Equipment logbook systems, commonly used for biopharmaceutical products. Experience with analytical equipment validation supporting biopharmaceutical processes. Experience as a project team-member for capital projects and proficient with computers, integrated systems, databases, and tools that support validation activities and project management. Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
Ability to interact well with peers and senior personnel in multidisciplinary teams involving scientific, engineering, and operational disciplines. Demonstrated ability to work on multiple projects, the ability to focus on the important projects, and the flexibility to adapt to changing priorities. Working knowledge of government regulations, current industry standards and practices, and quality principles relevant to validation. Self-starter, self-directed initiative, and multi-tasking, with strong organizational and communication skills. Knowledge of current standards for computer and Software validation with regard to:
Data Integrity Software Testing Computer Hardware Testing System Testing Electronic Records and Signatures Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. LI-GSK
Salary Range:
$100K -- $150K
Minimum Qualification
Systems Architecture & EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelors degree in a science displace with at least 5
years experience developing technical knowledge of enterprise, laboratory, and manufacturing systems such as LIMS, MES/ electronic batch / Equipment logbook systems, commonly used for biopharmaceutical products. Experience with analytical equipment validation supporting biopharmaceutical processes. Experience as a project team-member for capital projects and proficient with computers, integrated systems, databases, and tools that support validation activities and project management. Preferred
Qualifications:
If you have the following characteristics, it would be a plus:
Ability to interact well with peers and senior personnel in multidisciplinary teams involving scientific, engineering, and operational disciplines. Demonstrated ability to work on multiple projects, the ability to focus on the important projects, and the flexibility to adapt to changing priorities. Working knowledge of government regulations, current industry standards and practices, and quality principles relevant to validation. Self-starter, self-directed initiative, and multi-tasking, with strong organizational and communication skills. Knowledge of current standards for computer and Software validation with regard to:
Data Integrity Software Testing Computer Hardware Testing System Testing Electronic Records and Signatures Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. LI-GSK
Salary Range:
$100K -- $150K
Minimum Qualification
Systems Architecture & EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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