54 applicants

Company

Original Job Post

Katalyst HealthCares & Life Sciences · 2 days ago

Senior Validation Engineer

Jersey City, NJ

Contract

Onsite

Senior Level

5+ years exp

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Comp. & Benefits

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Responsibilities

Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects.

Prepare and execute commissioning / validation lifecycle documents.

Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade.

Write summary reports for validation and qualification protocols.

Support project milestones, priorities and deadlines.

Write operating procedures for technical equipment and practices and procedures.

Perform system and process risk assessments and analyses.

Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management.

Develop project specific validation plans and strategy.

Able to manage and execute multiple projects to meet client's priorities.

Provide a practical approach to problem solving.

Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers.

Qualification

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GMP experienceScientific knowledgeValidation principlesSMERegulatory complianceTechnical writingMicrosoft WordExcelPower PointProblem-solvingCommunication

Required

Bachelor's degree in a related life sciences or requisite industry training and experience

5-10 years GMP experience

Ability to converse about scientific matters

Ability to work independently or in collaboration with others

In-depth understanding and application of validation principles, concepts, practices and standards

Considered a Subject Matter Expert (SME) in one area of validation

Proficient in current Good Manufacturing Practices and other applicable regulations

Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report)

Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards

Excellent written communication skills with emphasis on technical writing

Proficient in Microsoft Word, Excel, Power Point and Project

Company

Katalyst HealthCares & Life Sciences

Katalyst Healthcares & Life Sciences offers data management, analysis, quality assurance, pharmacovigilance, and human resource services.

South Plainfield, New Jersey, USA

51-200 employees

http://katalysthls.com

H1B Sponsorship

Katalyst HealthCares & Life Sciences 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 (20)

2022 (46)

2021 (43)

2020 (53)