Project Engineer

RoslinCT US•Hopkinton, MA

2d•$77,000 - $115,000

About The Position

The Project Engineer executes and provides engineering support for the procurement, enrollment, and installation of equipment and systems, and supports validation and commissioning activities. The role develops and reviews related documentation and collaborates with Quality Assurance to ensure compliance with worldwide regulatory requirements and corporate standards. The position supports equipment implementation and activation, assesses GXP applicability and GAMP categorization, authors user requirement specifications, and contributes to risk assessments, change controls, HSE, qualification, and maintenance. It also manages and supports commissioning and qualification projects; authors, executes, reviews, and approves validation documentation; and ensures qualifications and requalifications are completed accurately and on time. The Project Engineer works with manufacturing, process development, QC, MS&T, and Quality Assurance teams using a risk-based approach, and may provide technical assistance to less experienced staff and customer support. Work may take place in a clean-room production environment requiring gowning and use of a fit-tested mask as needed. Flexible shift hours, weekends, and on-call availability may be required. RoslinCT describes its workplace as flexible and empowering, with an emphasis on work-life balance and employee development. Compensation is based on factors including education, experience, expertise, skills, market demand, internal equity, and business needs.

Requirements

Bachelor's degree or equivalent in engineering or science and at least 6 years of experience; alternatively, a master's degree and at least 4 years of experience, or a high school degree and at least 10 years of experience.
Hands-on experience in biotechnology, pharmaceutical, or medical device operations, including protocol development and field execution.
Working knowledge of the validation lifecycle approach, including DQ, IQ, OQ, PQ, PV, and RQ.
Knowledge of applicable US and worldwide regulatory requirements, such as GMP, GDP, and ICH.
Ability to develop and/or review protocols using design documents and user requirements.
Ability to manage medium- to large-sized commissioning and qualification projects.
Ability to perform thorough statistical analysis of validation test results.
Excellent technical writing and verbal communication skills.
Ability to investigate and troubleshoot system or testing failures.
Ability to read and interpret engineering drawings, such as P&IDs and PFDs.
Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Project, and Visio.
Ability to work in a clean-room production environment with gowning requirements.
Ability to wear a fit-tested mask for PPE as needed.
Ability to work flexible shift hours and weekends as needed and be on call as needed.

Responsibilities

Provide engineering support for procurement, enrollment, implementation, activation, and installation of equipment and systems.
Assess GXP applicability and GAMP categorization for new equipment based on intended use.
Author user requirement specifications and support risk assessments for equipment user requirements.
Develop, review, and approve documentation required in cGMP operations, and support equipment change control.
Assist with HSE, qualification, and maintenance activities as needed.
Manage and support equipment and system commissioning and qualification projects.
Author, execute, review, and approve validation protocols, reports, data, plans, and change controls as required.
Assist with drafting commissioning and qualification procedures and training documents or tools.
Ensure assigned IQs, OQs, PQs, and requalifications are completed correctly and on time.
Draft and support development of validation lifecycle documentation, including validation plans.
Provide QC lab validation review (LEQ) as required.
Present and defend validation studies during regulatory inspections and internal audits.
Collaborate with Manufacturing, PD, QC, MS&T, and Quality Assurance using a risk-based approach.
Interpret P&IDs, equipment and system layouts, wiring diagrams, and specifications for engineering and commissioning/qualification work.
Revise, review, and approve engineering and commissioning/qualification SOPs.
Generate deviations and CAPAs, conduct investigations, and perform root cause analysis.
Provide technical assistance to less experienced technicians and engineers.
Provide responsive customer support with an emphasis on customer satisfaction.