Job details
Job type full-time
Not provided by employer
Full job description
Job
: engineers, scientists & tech
Primary location
: americas-us-az-flagstaff
Other locations
: americas-us-az-phoenix travel% : 10%
Shift
: day
Schedule
: full-time
Senior validation engineer - 221758
About us: gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our associates.
About the industry: saving lives and improving the quality of life for patients is at the core of everything we doThis meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of othersLearn more at gore.com/products/industries
About the role: we are looking for a senior validation engineer to join our process engineering role excellence teamIn this role, you will partner with the process validation champion and validation process owner, while serving various teams by completing medium to high complexity validation projectsThis role provides the opportunity to work across a diverse range of products, processes, technologies, and facilities, based on business needs; while applying knowledge, skills, and experience in validation-related competencies to effectively fulfill high priority, excess or unplanned validation needs by qualifying equipment, software, and processes.
This position offers multiple work arrangements, including on-site at our facility in flagstaff, arizona or phoenix, arizonaHybrid and fully remote work allowed in most locations within the united states, depending upon the responsibilities of the role and business needs.*
Responsibilities:
Drive medium to high complexity validation projects, completing on-time and on-budget
Identify and perform validation / qualification (iq/oq/sqa/poq/pq) activities by planning projects, writing protocols (vps), executing validation testing using alcoa+ principles, writing reports (vrs), and implementing quality system documents
Apply project management skills and partner with internal customers to define & manage priorities, uncertainties, deliverables, timelines, and address roadblocks
Apply requirements management and risk management to maintain traceability to system / process requirements (urs, frs, sds, etc) and develop risk-based test cases
Collaborate with d&a, suppliers, process design, and process control engineers to understand systems / processes and review pre-validation testing, when applicable (uat, fat, sat)
Coordinate validation support by applying cross-functional collaboration to effectively communicate and partner with other roles / functions (engineering, manufacturing, technicians, shop services, em&c, eh&s, qa, mrb, etc.)
Partner with other validation smes (champion, process owner, sqa) to align with divisional guidance and apply current divisional best practices and templates
Provide mentorship to experienced engineering associates
Provide input to divisional validation improvement projects and participate in pe community of practice (cop)
Track validation project metrics, identify challenges, and help evaluate role effectiveness
Required qualifications:
Bachelor’s degree in an engineering field or equivalent work experience
Minimum of 5 years experience with qualifying / requalifying equipment, software, and/or processes within a cgmp/gxp environment
Proven history of communicating effectively and writing technical documents, including protocols, reports, and validation records
Demonstrated understanding of compliance and validation regulatory requirements in medical device industry
Demonstrated ability to identify requirements and translate them into clear, objective test plans, using effective risk-based decision making
Demonstrated ability to apply engineering fundamentals and statistical tools to validation activities
Demonstrated ability to prioritize, plan, and drive multiple projects concurrently from development to completion against agreed upon timelines and deliverables
Demonstrated ability to work independently and collaborate effectively as part of a team, including influencing across functions
Demonstrated ability to leverage critical thinking to navigate technical and project uncertainties
Ability to travel up to 10%
Desired qualifications:
Experience facilitating process validation course and/or providing mentorship in validation
Experience applying good automated manufacturing practices (gamp) to configured / custom (category 4/5) systems, quality by design (qbd) / critical to quality (ctq) and/or computer software assurance (csa), and validating systems to meet 21 cfr part 11 requirements
Experience maintaining requirements traceability matrices, performing functional risk assessments, and identifying risk mitigating controls
*remote working arrangements are permitted for associates in the continental united states (us) and canada, with appropriate approval and compliance with gore’s remote working policies, from the country in which they are employedLocations not eligible for new remote work arrangements include: alaska and hawaii (for all roles), and rhode island (for wage/hourly roles only).
What we offer: at gore, we offer comprehensive, competitive rewards in the form of compensation and benefitsAmong these are work-life balance and sports programs, 401(k) plan with a gift, associate stock ownership plan, health & well-being program with full health plan, and a flexible working programWithin gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and developmentLearn more at gore.com/careers
We believe in the strength of a diverse workforce and inclusive work environmentIn support of our values and continued success we are proud of associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all associates and external partners are treated with fairness, dignity and respect.
Gore is committed to a drug-free workplaceAll employment is contingent upon successful completion of drug and background screeningGore requires all applicants to be eligible to work within the u.sGore generally will not sponsor visas unless otherwise noted on the position descriptionGore is a m/f, disabled and vet eeo/aa employer(applies to all positions in the u.s.) our talent acquisition team welcomes your questions at gore.com/careers/contact #li-msl #li-hybrid
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Posted 11 days ago
