USA - Montana - Hamilton
Sep 13 2019
225853 Validation Engineer
As a Validation Engineer you will manage directly implement, execute and support the validation strategy at use at the GSK Hamilton Site ensuring it is harmonized with local, regulatory, and GSK standards.
They manage, schedule, coordinate and execute assigned qualification or validation activities under the supervision of SME to ensure timely completion of the Validation Plan in coordination with the User, Technical Services, Quality Control, Quality Assurance and Regulatory departments.
Finally, they 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, 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 of standard operational procedures 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.
- Support the Multi-Site Validation (MSV) SME in Equipment Qualification.
Support Equipment Qualification Clean Systems (Autoclaves, Oven, Cleaning, Clean Utilities, Environmental, Filtration, etc.)
- Supports the site qualification, requalification and continuous monitoring plan (autoclaves, oven, cleaning, etc.)
- Supports the systems SME during audits.
- Coordinates and supports validation and qualification activities (DQ/IQ/OQ). Authors, reviews, and approves protocols and provides training on protocol execution.
- Reviewing executed protocols for completeness, cGxP compliance, data acceptability and data integrity validation SME for impact assessments and root cause analysis for Deviations , Corrective Action/Preventative Action Reports, Outlier Reports, and assist with other investigations (OOT, etc.) related to clean systems.
- 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:
- Bachelor Degree
- Experience in Pharmaceutical or related industry.
- Demonstrated awareness of 3 or more elements of validation including but not limited to:
o Computer systems
o Equipment Qualification (DQ/IQ/OQ/CAT/AAT)
o Cleaning Validation
o Steam Sterilization
o Dry Heat depyrogenation
o Environmental Monitoring
o Clean Utilities Qualification
o Process Validation
o Validation of Aseptic Processing
o Automation Qualification
o HVAC, Smoke Studies, and EM Qualification
o Method Validation
o Single Use Systems
Demonstrated ability in the following:
Adept at working both as an individual and in varying groups in a dynamic, multi-tasking environment.
Ability to work on multiple projects, ability to prioritize and flexibility to adapt to changing priorities.
If you have the following characteristics, it would be a plus:
- Technical writing organizational, communication and team skills.
- Ability 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
- SAP experience
- Use and understanding of SAP system.
Our values and expectations are 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:
v Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
v Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
v Continuously looking for opportunities to learn, build skills and share learning.
v Sustaining energy and well-being
v 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 HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. 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.
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