Project Engineer Associate

WHO WE ARE

We at RoslinCT, are a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s 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, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Project Engineer will execute and provide engineering support for the procurement, enrollment, and installation of equipment and systems. They will also support 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

• Provide engineering support for procurement, enrollment, and installation of equipment and systems:
• Assist with equipment enrollment, implementation and activation.
• Assist with assessments of GXP applicability and GAMP categorization for new equipment based on intended use.
• Author user requirement specifications for equipment/systems.
• Support risk assessments for equipment user requirements
• Review, and approve accurate documentation, as required in cGMP operations.
• Change control management/support for equipment.
• Assist with HSE, Qualification and Maintenance activities as needed
• Provide support for Validation and Commissioning Activities:
• Support equipment and system commissioning and qualification projects.
• Author, execute, review, and approve Validation protocols, reports, data, plans, change controls, etc., as required.
• Assist with revision of commissioning/qualification procedures and training documents/tools.
• Execute assigned qualifications (IQs, OQs, and PQs) and requalification (RQs) on-time and correctly.
• Support the development of Validation lifecycle documentation (e.g., Validation Plans).
• Provide QC lab validation review (LEQ) as required.
• Support for these activities will be accomplished by:
• Working in a collaborative team environment and interact with other support groups such as Manufacturing, PD, QC, MS&T, and Quality Assurance using a risk-based approach.
• Interpreting P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing engineering and commissioning/qualification activities.
• Perform engineering and commissioning/qualification SOP revision, and review.
• Generate deviations, CAPAs, perform investigations and root cause analysis.

Qualifications

• Bachelor's degree (or equivalent) in engineering/science and 2 years experience
• Masters degree and 1 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
• Ability to execute medium to large size commissioning/qualification tasks
• Ability to perform thorough statistical analysis of validation rest results
• Excellent technical writing and verbal communication skills
• Ability to investigate/troubleshoot system/testing failures
• Ability to read/interpret engineering drawings (e.g. P&IDs, PFD’s)
• 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 COMMITTMENT

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.