Validation Engineer - Remote

Overview

The Validation Engineer will ensure the integrity and reliability of systems and processes through rigorous testing and validation. Utilize technical expertise to develop and execute validation protocols, ensuring compliance with industry standards and regulatory requirements.

In Short

• Perform equipment qualifications including Commissioning, IQ, OQ, and PQ.
• Travel both locally and internationally to help serve various clients.
• Write, review, approve, and execute validation protocols.
• Create reports summarizing results and statistics.
• Develop and communicate expectations for quality performance, continuous improvement, and quality systems.
• Assist developers and domain experts in designing, performing, and improving verification tests.
• Ensure validation program meets GMP, FDA, and ISO regulations.
• Work with scientists, technicians, engineers, and project management to deliver validated equipment and facilities.
• Interact with cross-disciplinary teams in order to meet project milestones and end goals.
• Collaborate with key stakeholders and client teams to help define needs and achievable solutions and/or justifications for equipment requirements and related validation.

Requirements

• Bachelor’s degree in a related life science field.
• 4-7 years of experience within the biotech, pharmaceutical, or medical device industry.
• Willingness to travel up to 75-100% for projects at client sites.
• Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis, required.
• Validation expertise in Equipment, CSV, Method, and Process - Fill Finish a plus.
• Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation.
• Report writing experience for IQ, OQ, PQ, and CSV.
• Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired.

Benefits

• Market competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Ongoing recognition and career development opportunities.
• Generous flexible paid time off program.
• Company paid holidays.
• Flexible working hours.
• Fully remote work options for most positions.
• Ability to work “almost anywhere”.
• Office locations in Greater Boston, San Diego, CA, Boulder, CO, and India.