Project Engineer

RoslinCT; Hopkinton (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

RoslinCT in Hopkinton, MA is hiring a Project Engineer to drive engineering support for procurement, enrollment, and installation of equipment and systems. You will work with QA to ensure regulatory alignment and contribute to validation planning and documentation.

Ideal candidates will have hands-on biotech or pharma operations experience, strong technical writing and communication skills, and the ability to manage medium-to-large commissioning projects in a fast-paced cGMP environment.

Qualifications

• Bachelor's degree in engineering or science, plus 6+ years experience.
• Master's degree with 4+ years experience or high school with 10+ years experience.
• Hands-on Biotech/Pharma/Medical Device operations experience including protocol development.
• Knowledge of Validation Lifecycle: DQ, IQ, OQ, PQ, PV, RQ.
• Familiarity with GMP, GDP, ICH regulations.

Responsibilities

• Support procurement, enrollment, and installation of equipment/systems.
• Manage equipment enrollment, implementation, and activation.
• Develop and review validation protocols, reports, and related documentation.
• Assist with commissioning/qualification activities and change controls.
• Collaborate with QA, Manufacturing, QC, MS&T, and other groups.

Skills

Technical writing

Verbal communication

Reading engineering drawings

Problem solving

Education

Bachelor's degree in engineering/science

Master's degree +4+ years experience

High School +10+ years experience

Tools

Microsoft Office

Visio

MS Project

Job description

Who We Are

RoslinCT is a world-leading cell 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.

Who We Are

RoslinCT is a world-leading cell 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 and delivery 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:
• Manage equipment enrollment, implementation and activation.
• Assess 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
• Develop, 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:
• Manage and 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 drafting of accurate commissioning/qualification procedures and training documents/tools.
• Ensure assigned qualifications (IQs, OQs, and PQs) and requalifications (RQs) are completed on-time and correctly.
• Draft and support the development of Validation lifecycle documentation (e.g., Validation Plans).
• Provide QC lab validation review (LEQ) as required.
• Present and defend validation studies during regulatory inspections and internal audits.
• 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, review, and approval.
• Generate deviations, CAPAs, perform investigations and root cause analysis.
• Provide technical assistance to less experienced technicians/engineers.
• Provide responsive customer support with emphasis on customer satisfaction.

Qualifications

• Bachelor's degree (or equivalent) in engineering/science and 6+ years experience
• Masters degree and 4+ years experience or High School degree with 10+ 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 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, 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.

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.

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.