Overview

Summary of job description:

The Validation Engineer II will work as part of a larger validation team to ensure the biotech facility equipment, utilities, instrumentation and computerized systems are qualified and maintained in a validated state in accordance with appropriate regulatory guidance. The individual will work with internal customers and external contractors to coordinate scheduling, execution, and review of qualification protocols / reports. The individual will project manage CQV campaigns and data integrity assessments to support maintaining CQV through change control, assessments, performance monitoring and requalification assessments.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Responsibilities

Key responsibilities:

• Establish, revise, and maintain validation plans and procedures for qualification of equipment required for cGMP compliance.
• Be responsible for writing and executing qualification protocols and report generation, including acceptance criteria generation.
• Coordinate scheduling, execution & review of qualification protocols / reports.
• Manage vendors and contractors performing qualification activities.
• Manage projects associated with computerized equipment and computer system validation (CSV).
• Generation and execution of data integrity assessments.
• Perform equipment requalification to ensure utilities and equipment remain compliant with required procedures and regulations.
• Review, revise, and complete documentation in accordance with cGMP.
• Ensure equipment and building monitoring systems remain in validated compliance and support updates as new equipment added.
• Provide impact assessments for change controls and deviations related to validated status of utilities, equipment, instruments, and systems.
• Assist with trouble shooting equipment / system failures.
• Serve as key member of project teams for design, procurement and installation of new equipment and facility expansion projects. Responsibilities will include support of design, selection, commissioning and qualification of utilities and equipment.

Other responsibilities

• Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (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.
• Ensure training is kept in GMP compliant state.

Qualifications

Educational requirements:

• Bachelor’s degree in Scientific, Engineering or similar subject required, MSc preferred.

Experience and skill requirement:

• A minimum of five years professional experience in validation, engineering, or operations.
• A minimum of three years relevant experience in a cGMP environment is preferred.
• Experience with GMP utilities and equipment is preferred.
• Experience with DIA and CSV is required.
• Excellent communication and interpersonal skills are required. Attention to detail, flexibility and technical writing skills are important for this position.
• Good knowledge cGMP & GDP requirements
• Ability to work independently or in a team environment as well as being self-motivated and showing initiative.

Location: 

This position is based in our Framingham location and typically has a 5-day on-site expectation.