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Senior Validation Engineer

Employer
Katalyst Healthcares & Life Sciences
Location
Five Corners, NJ
Closing date
Jul 25, 2024

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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.

Requirements:

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.

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