Validation Engineer - Hopkinton, United States - RoslinCT

Description

WHO WE ARE

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change peoples lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, peoples development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Validation Engineer will execute and provide oversight of equipment and systems validation and commissioning activities. This critical role will develop and review related documentation and collaborate with Quality Assurance to ensure adherence to world-wide regulatory requirements and corporate standards.

HOW YOU WILL MAKE AN IMPACT

• Perform equipment and system validations.
• Develop, review, and approve accurate documentation, as required in cGMP operations.
• Provide responsive customer support with emphasis on customer satisfaction.
• Work in a collaborative team environment and interact with other support groups such as Manufacturing, PD, QC, MS&T, and Quality Assurance.
• Assist with HSE, Qualification and Maintenance activities as needed.
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing commissioning/qualification activities.
• Assist with drafting of accurate commissioning/qualification procedures and training documents/tools
• Ensure assigned re-qualifications (RQs) are completed on-time.
• Provide QC lab validation review (LEQ) as required.
• Review Validation protocols, reports, data, plans, change controls, etc., as required.
• Provide technical assistance to less experienced technicians/engineers.
• Work as part of a team to ensure that commissioning/qualification activities are completed on-time and correctly.
• Work as part of a multi-disciplinary team for Commissioning/Qualification using a science and risk-based approach.
• Manage medium to large size commissioning/qualification projects and change control-based qualification activities.
• Develop Validation Plans for validation projects.
• Perform SOP revision, review, and approval.
• Generate deviations, CAPAs, perform investigations and root cause analysis.
• Work with Quality Assurance on the revision of validation documents (e.g. Master Plans, Requalification program)
• Present and defend validation studies during regulatory inspections and internal audits.

WHAT YOU WILL BRING

• Bachelor's degree (or equivalent) in engineering/science
• 4+ years experience hands-on experience in Biotech, Pharmaceuticals or Medical Device operations, including protocol development and field execution.
• Working knowledge of Validation Lifecycle Approach (DQ, IQ, OQ, PQ, PV, and RQ)
• Knowledge of applicable US and worldwide regulatory requirements (e.g. GMP, GDP, ICH)
• Ability to develop and/or review protocols using design documents and user requirements.
• Experience with chamber temperature mapping, tubing welders, and Biosafety cabinets are a plus.
• Ability to manage medium to large size commissioning/qualification projects.
• Ability to perform thorough statistical analysis of validation rest results.
• Excellent technical writing and verbal communication skills
• Ability to Investigation/troubleshooting system/testing failures
• Ability to read/interpret engineering drawings (e.g. P&IDs, PFDs)
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.

Working conditions

• Ability to work in clean room production environment with gowning requirements.
• Must be able to wear a fit tested mask for PPE as needed.
• Must Be able to work Flexible hours on Shifts and weekends as needed.
• Ability to be on call as needed.

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.