Senior Process Engineer - Compliance #4968
grailbio · Durham, NC ·
- Work mode
- Onsite
- Seniority
- Senior
- Employment
- Full time
- Category
- Industrial engineering
- Experience
- 2+ years
grailbio · Durham, NC ·
The Senior Process Engineer leads complex investigations, compliance related initiatives and supports document management processes. This role is primarily responsible for driving quality management system (QMS) activities across engineering, validation, clinical laboratory and operations, including change control management, SOP lifecycle oversight, nonconformance (NC) and CAPA metrics management, training compliance, and continuous process improvement. The Senior Process Engineer works across functions to design and implement process improvements, serve as a technical resource to peers and technicians, and ensure compliance with regulatory and quality requirements.
In addition, this role provides advanced technical expertise in high-complexity molecular diagnostic workflows supporting the Galleri® assay and collaborates cross-functionally to ensure operational excellence, regulatory readiness, and sustained compliance with applicable regulatory and accreditation requirements.
This position works full time onsite in Durham, NC.
Lead and own quality management system (QMS) activities, including change controls, document control, SOP revisions, deviations/nonconformances (NCs), and corrective and preventive actions (CAPAs).
Develop and maintain work instructions, guidelines, verifications, and standard operating procedures.
Independently investigate and resolve process deviations, applying root cause analysis and implementing effective corrective and preventive actions.
Support internal audits, external inspections, and regulatory assessments; prepare documentation, evidence packages, and responses to audit observations.
Partner cross-functionally with Quality Assurance, Regulatory Affairs, Engineering Operations, Validation, and Clinical Operations leadership to implement and sustain compliant processes.
Identify process gaps, compliance risks, and operational inefficiencies; recommend and implement sustainable corrective actions and process improvements.
Mentor and train personnel on workflows, quality processes, and regulatory expectations.
Provide technical guidance and support to engineers and technicians to promote process understanding and standardization.
Prepare and present technical reports, proposals, and recommendations to management for process enhancements and cost savings.
Develop training compliance processes, including assignment, completion tracking, and on the job training assessments.
These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.
Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or related field) with 5+ years of relevant experience, or Master’s degree with 3+ years of relevant experience, or PhD with 2+ years of relevant experience.
Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
GMP quality management systems (e.g. ISO 13485)
Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)
Operations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)
Experience supporting audits, inspections, and regulatory readiness activities.
Proven ability to manage multiple priorities and drive projects to completion in a fast-paced regulated environment.
Strong working knowledge of quality management systems (QMS) and regulated laboratory/manufacturing operations.
Expertise in change control, CAPA management, deviation/nonconformance investigations, and document control processes.
Strong analytical and organizational skills with the ability to manage metrics, trend data, and compliance reporting.
Excellent written and verbal communication skills, including technical writing and audit documentation.
Strong collaboration and stakeholder management skills across cross-functional teams.
Process improvement mindset with demonstrated success driving operational and quality improvements.
Experience in executing within computerized maintenance/calibration equipment management systems.
Excellent communication skills to influence and collaborate across departments and present technical findings.
Leadership skills to mentor junior engineers and lead cross-functional teams.
Strong project management and organizational skills; able to manage multiple workstreams with competing priorities
Work performed in office, laboratory, and manufacturing production environments.
Regular interaction with production equipment, requiring PPE such as safety glasses, gloves, lab coats, or cleanroom garments.
Frequent standing, walking, and occasional lifting of 25–30 lbs.
Exposure to chemicals, noise, and temperature variations in production areas.
May require flexible hours, overtime, or weekend work to support production or project deadlines.
At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.
At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.
GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [email protected] if you require an accommodation to apply for an open position.
GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!