CSV Engineer III (On-site in College Station, TX)

FUJIFILM Biotechnologies; United States; On-site; USD 63,000 - 132,000; Full time

Job summary

A leading company in biotechnology is seeking a Computer System Validation Engineer III to oversee the development and approval of critical validation documentation. This role requires strong validation experience and knowledge of regulatory compliance in FDA-regulated environments. You will collaborate with project teams to ensure optimal risk assessments and validation deliverables meet industry standards.

Benefits

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Tuition assistance

Qualifications

• 2+ years of validation experience in FDA-regulated environments.
• 4+ years of validation experience in FDA-regulated environments.
• 6+ years of validation experience in FDA-regulated environments.

Responsibilities

• Lead development and approval of validation documentation.
• Conduct impact assessments of proposed changes.
• Plan validation activities across cross-functional teams.

Skills

Knowledge of DeltaV automation platform

Working knowledge of engineering principles

Communication skills

Education

Master’s Degree in relevant field

Bachelor’s Degree in relevant field

Associates Degree in relevant field

Tools

Microsoft Office

Job description

Direct message the job poster from FUJIFILM Biotechnologies

The Computer System Validation (CSV) Engineer III, under general direction, will lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.

Reports to Associate Director, Validation

Work Location College Station, TX

Primary Responsibilities:

• Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
• Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
• Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports).
• Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation, and industry codes.
• Perform other duties as assigned.

Qualifications:

• Master’s Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
• Bachelor’s Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR;
• Associates Degree with 6+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.
• Knowledge of DeltaV automation platform.
• Working knowledge of engineering principles.
• Working knowledge and expertise in computerized systems validation.
• Computer System Validation experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred.
• Knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations.
• Excellent written and oral communication skills.
• Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
• Ability to work with minimal supervision.
• Desire to work 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at FUJIFILM Biotechnologies by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid paternity leave

Paid maternity leave

Tuition assistance

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