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Company

Original Job Post

Thermo Fisher Scientific · 3 days ago

Staff Validation Engineer

Middletown, VA

Full-time

Onsite

Senior Level

10+ years exp

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BioinformaticsBiotechnology

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Responsibilities

Serve as the primary interface between Operations and Quality Assurance.

Originate and assist in the preparation and approval of change orders related to the operation and improvement of manufacturing processes.

Assist the validation team in maintaining the Site Validation Master Plan.

Support development projects, transfer projects, process changes, and engineering projects to provide overall guidance as it relates to quality standards, inspection techniques and frequencies, statistical analysis, testing, validations, and risk assessments (FMEAs).

Direct and oversee validation activities for Operations, Engineering, Quality Assurance, and other functional areas.

Review, revise, and maintain site validation procedures, qualification protocols, and associated data in accordance with FDA and ISO requirements.

Lead and/or assist in training of staff involved in validation activities.

Assist Quality, Operations, and Engineering personnel during inspections or audits.

Performs other duties as assigned by Staff Validation Engineer and direct manager.

Qualification

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Validation protocol developmentTechnical writingData analysisReport generationProcess + packaging equipment knowledgeSoftware validation principlesCleaning validation proficiencyStatistical analysisProcess control proficiencyCleaning process design proficiencyValidation plans developmentFDAISO requirements knowledgeProcess controls knowledgeProduct/process risk assessments knowledgeProblem-solvingHigh level of expertiseHandle prioritization changesInfluenceCoordinate activities organizational skillsEffective communicationResolve conflictsManage multiple projects simultaneouslySolving project-related conflictsISO 1348521 CFR Part 820Microsoft OfficeMedical Device ExperienceQuality Requirements

Required

Bachelor’s degree from a four-year college or university and 10+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry with progressively increasing responsibilities is required.

Associate degree and 15+ years of relevant experience in the pharmaceutical, medical device, or in-vitro diagnostics industry with progressively increasing responsibilities is required.

Must be proficient on validation protocol development, technical writing, data analysis, and report generation. i.e.; IQ, OQ, PQ, FAT, SAT as an example.

Must have knowledge of process + packaging equipment, and software validation principles and concepts.

Must have high level of expertise concerning current validation principles and regulatory requirements.

Must be able to handle prioritization changes in a fast-paced environment.

Strong understanding and proficiency in cleaning validation and cleaning process design.

Must be proficient in statistical analysis and process control.

Must be able to influence and coordinate activities of personnel over which he/she has no direct authority.

Must possess strong organizational skills.

Must be able to effectively communicate with all levels of the organization, from the General Manager to the production operators.

Must be able to resolve conflicts between requests for process change and the validation requirements for those processes.

Develop and execute verification and validation plans and protocols associated with product/process quality according to FDA and ISO requirements.

Ability to manage multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members and support personnel, and solving project-related conflicts and issues.

Strong working knowledge of design and process controls.

Travel when required to support business projects as a validation representative.

Knowledge of process and product risk assessments.

Preferred

Knowledge of global regulatory and quality requirements associated with medical devices.

Working knowledge of ISO 13485 and 21 CFR Part 820.

Experience with formal problem solving in a team environment.

Detail oriented with the ability to lead multiple projects and activities as assigned.

Proficiency in Microsoft Office products (i.e. Mini Tab, Excel, Outlook, PowerPoint, etc.).

Previous medical device (Class II or Class III) experience required (from product development, validation engineering, sustaining engineering or manufacturing engineering).

Must have good oral and written communication skills. This includes interfacing with external customers and internal Senior Management.

Proficiency with various software platforms such as Minitab, Blue Mountain RAM, and Master Control is preferred.

Benefits

Healthcare

Company Pension/Retirement

Range of Employee Benefits

Company

Thermo Fisher Scientific

Glassdoor

3.6

Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Founded in 1956

Waltham, Massachusetts, USA

10,001+ employees

http://www.thermofisher.com

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (173)

2022 (314)

2021 (349)

2020 (251)