Validation Engineer x

Validation Engineer x 3 at The Autumn Group

Position Summary

The Validation Engineer will report to the VCGT Validation leadership or an appropriate designee to execute Commissioning, Qualification and Validation activities.

Key Responsibilities

• Draft and implement Quality System documentation designed to establish good validation practices within the organization.
• Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
• Support all stages of qualification of Analytical Instrument and Manufacturing equipment.
• Support all stages of qualification of automated manufacturing equipment.
• Conduct Analytical Instrumentation Qualifications in accordance with USP and Vertex SOPs.
• Conduct Automation Assessments to ensure compliance with 21 CFR Part 11.
• Coordinate with vendor personnel to schedule and execute test plans, if required.
• Coordinate with internal stakeholders to safely and effectively schedule CQV activities, whenever required.
• Effectively work with cross departmental stakeholders, including but not limited to information services, EH&S, Global Security, design teams, and quality.
• Author documents related to or support process validation related activities that include but not limited to aseptic process simulations (Client), process performance qualification, material qualifications, etc.
• Develop cycles for sterilization processes and validate them, if required.
• Completes assigned training and ensures that they are 100% compliant 100% of the time.
• Ensure that all Validation activities align with the current SOPs, global standards and cGMP guidelines.
• Supports right-the-first-time culture for all documents distributed across the organization. Ensure the VCGT Validation team reputation and partnership is flourished with the cross-functional teams.

Ideal Candidates

• Demonstrated ability to safely execute Validation activities in a dynamic fast paced environment.
• Experience developing and executing Validation protocols in a GMP Manufacturing and Analytical Laboratory areas.
• Receptive to change – Adapts (quickly) to changing circumstances.
• Flexibility for off-shift hours, including weekend and night shift work.
• B.A, B.S. in Engineering or related discipline with 5-8 years of Validation experience or equivalent professional experience.
• Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.

Seniority level
:
Mid-Senior level

Employment type
:
Full-time

Job function
:
Quality Assurance

Industries
:
Biotechnology Research and Civil Engineering

Location:

Boston, MA

Salary: $42,000.00 – $50,000.00