Validation Engineer II

Validation Engineer II - Contract - Framingham, MA

Proclinical is collaborating with a biotechnology company who are seeking a Validation Engineer II for a role based in Framingham, MA, with a on-site expectation.

Primary Responsibilities:

In this position, you will be responsible for establishing and maintaining validation plans and procedures for equipment qualification at the manufacturing facility, ensuring compliance with regulatory guidance. You will coordinate with customers and external contractors, manage validation campaigns, and maintain the validated status of the facility and equipment.

Skills & Requirements:

• BS in Scientific, Engineering, or a similar subject.
• Professional experience in validation, engineering, or operations.
• Relevant experience in a cGMP environment is preferred.
• Experience with GxP Computer System Validation (CSV) on SaaS platforms.
• Familiarity with GMP utilities and equipment is preferred.
• Experience with data integrity assessments and CSV is preferred.
• Excellent communication and interpersonal skills.
• Attention to detail, flexibility, and technical writing skills.
• Good knowledge of cGMP and GDP requirements.
• Ability to work independently or in a team environment, self-motivated, and showing initiative.

The Validation Engineer II's responsibilities will be:

• Establish, revise, and maintain validation plans and procedures for equipment qualification required for cGMP compliance.
• Generate qualification protocols and reports, including acceptance criteria.
• Coordinate scheduling, execution, and review of qualification protocols/reports.
• Manage vendors and contractors performing qualification activities.
• Oversee projects related to computerized equipment and computer system validation (CSV).
• Ensure GxP computer-based systems operate as intended and meet regulatory requirements.
• Perform data integrity assessments and equipment requalification.
• Review, revise, and complete documentation in accordance with cGMP.
• Ensure equipment and building monitoring systems remain in validated compliance.
• Provide impact assessments for change control and deviations related to validated status.
• Assist with troubleshooting equipment/system failures.
• Participate in project teams for new equipment and facility expansion projects, including design, selection, commissioning, and qualification of utilities and equipment.
• Ensure all work is performed in accordance with SOPs, cGMP, quality standards, and safety procedures.
• Support equipment and process-related non-conformance investigations and change control activities.
• Assist with internal and regulatory agency audits/inspections.
• Maintain GMP-compliant training status.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDEN