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Company

FUJIFILM Diosynth Biotechnologies · 1 day ago

Validation Manager (On-Site in College Station, TX)

United States

Full-time

Remote

Senior Level

7+ years exp

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BiotechnologyHealth Care

H1B Sponsor Likely

Hiring Manager

Lisa Cramer, MBA

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Responsibilities

Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals.

Supervises the activities of the corresponding manufacturing building’s internal validation staff as well as external validation contractors. Establishes validation priorities to ensure that deadlines are met.

Pre-approve qualification protocols and post-approve summary reports.

Perform assessments of all change controls with an accurate understanding of the implications of changes

Must be able to create, review, and update VPPs, SIAs, Risk Assessments, SOPs, forms, templates, documentation, and files.

Monitors the performance of the validation activities of the corresponding manufacturing building by tracking appropriate metrics and reporting the results to Validation’s Associate Director/Director.

Performs other duties as needed.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Validation experiencePharmaceutical industryBiotechnology industryFDA regulationsFUSE SystemsClean UtilitiesSterilization EquipmentTemperature Controlled UnitsISPE Baseline 5Supervision of personnelEngineering principlesMicrosoft Office

Required

Master’s Degree and 5+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;

Bachelor’s Degree and 7+ years of direct Validation experience in pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.

4+ years’ experience in supervision of personnel.

Demonstrated knowledge and experience in process systems associated with the manufacture of a biopharmaceutical product.

Strong Working knowledge of engineering principles.

Solid Working knowledge and expertise in FUSE Systems, including Classified Clean Rooms, Clean Utilities, Sterilization Equipment, Temperature Controlled Units (2-8 C, -80 C, LN2 Freezers, Incubators) among others.

In depth Knowledge ISPE Baseline 5, Vol. 2 – Commissioning and Qualification and FDA industry regulations.

Excellent written and oral communication skills.

Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).

Efficiently manages validation staff in fast-paced, state of the art, alternately research and customized manufacturing facility.

Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Preferred

Degree in Engineering or Science discipline is preferred.

Company

FUJIFILM Diosynth Biotechnologies

Glassdoor

3.4

Fujifilm Diosynth Biotechn, contract development & manufacturing provider for preclinical, clinical and commercial biologics manufacturing.

Founded in 2011

Morrisville, North Carolina, USA

1,001-5,000 employees

http://www.fujifilmdiosynth.com

H1B Sponsorship

FUJIFILM Diosynth Biotechnologies 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

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Trends of Total Sponsorships

2022 (1)

2021 (1)