GlaxoSmithKline Consumer Healthcare, L.P. Validation Engineer in Hamilton, Montana
Are you looking for an opportunity to manage projects, identify areas of improvement, and support safety working practices? If so, this is the job for you.
As a Validation Engineer you will be responsible for directly implementing, executing and supporting the validation strategy at use at the GSK Hamilton Site ensuring it is harmonized with local, regulatory, and GSK standards.
You will manage, schedule, coordinate and execute assigned qualification or validation activities under the supervision of Subject Matter Experts (SME) to ensure timely completion of the Validation Plan in coordination with the User, Technical Services, Quality Control, Quality Assurance and Regulatory departments. Finally, you will support maintaining all process and laboratory equipment, facilities, and critical systems/utilities at Hamilton site in a validated state.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Support all aspects of the validation life cycle from design through operation, improvement and retirement.
Develop, review, approve, execute and managing GxP system lifecycle documentation with support from experienced Validation Experts, including Validation Plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Traceability Matrix, Validation Reports, SOPs, Change Control Documentation, Risk Assessments, Validation Deviations and Qualification Summary Reports with Value Stream, Technical Services, Quality Control, Quality Assurance and Regulatory departmental representatives.
Support Validation SME in internal, external global and regulatory agency audits and system compliance risk assessments.
Generation, maintenance, and technical review for validation activities and site standard operating procedures.
Responsible for executing Periodic Validation Review activities
Maintain up to date knowledge of validation requirements, practices and procedures
Work with other departments to troubleshoot equipment, process and validation issues such as deviation impact assessments and root cause analysis.
Perform all job responsibilities in compliance with applicable EHS and GMP regulation, guidelines, policies and standard operating procedures.
Administer the computer validation program for the site, including the author/review/approval of, process control installation/operational qualification protocols, alarm acceptance testing, computer acceptance testing protocols and maintenance of computer systems in accordance with corporate and departmental procedures.
Support the Computer Systems SME during audits and assessments.
Reviewing completed protocols for completeness, cGxP compliance and data acceptability.
We are looking for professionals with these required skills to achieve our goals:
1+ year experience in Pharmaceutical or related industry
1+ year computer validation experience or 1+ year experience working with or computerized analytical equipment in a GMP setting
If you have the following characteristics, it would be a plus:
Demonstrated awareness of elements of validation including but not limited to: Computer systems validation, equipment qualification (DQ/IQ/OQ/CAT/AAT), laboratory equipment qualification
Demonstrated ability in the following: Adept at working both as an individual and in varying groups in a dynamic, multi-tasking environment. Able to work on multiple projects with the ability to prioritize and flexibility to adapt to changing priorities. Good technical writing, organizational, communication and team skills. Willingness to take initiative and work proactively with creative problem solving skills.
Certified Project Management Professional
Certified Quality Engineer
Certified Six Sigma Engineer
ASQ or equivalent Black Belt
ASQ or equivalent Green Belt
Use and understanding of SAP system.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.
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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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ViiV 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.