Staff / Senior Process Engineer #3509

WE STRONGLY ENCOURAGE OUR VETERAN COMMUNITY TO APPLY

The Staff/Sr Process Engineer will plan, develop, improve, organize, and implement the Equipment lifecycle program according to multiple regulatory bodies. They will also help improve our quality maturity in the engineering organization. This function will be responsible to reduce quality defects in our business and processes and provide practical GMP guidance and mentorship to our teams. The engineer will own and execute root-cause investigations, implement action plans for nonconformances, internal/external audits and other compliance related matters. GRAIL's processes are scaling fast and require a dynamic and detail oriented engineer to help deliver our revolutionary test to as many people as possible.

Expected schedule is on-site Monday through Friday in Durham, NC (RTP Site)

This position may need to support weekends and holidays.

Alternative locations and work arrangements could be considered.

Responsibilities;

• Assure compliance with SOX, CLIA/CAP, FDA 21 CFR part 820, ISO 13485, IVDR requirements

• Create and update work instructions, guidelines, verifications, and standard operating procedures (SOP)

• Develop roadmaps and lead initiatives to ensure long term compliance sustainability

• Leads CAPAs and associated quality investigations

• Participate, be a role model, and adhere to GRAIL's policies and guidelines

• Provide training, support in the creation of new training, and transfer knowledge

• Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process

• Supports audit readiness and on-site audits

• Work closely with Quality and regulatory to implement and follow the required policies and procedures for the lifecycle of equipments

• Anticipates and resolves conflict situations in a win - win outcome

Preferred qualifications;

• 5+ years of related experience with a BS/BA or higher degree in Engineering or Life Sciences or equivalent

• Experience executing within a computerized maintenance/calibration management system, product lifecycle managements systems, and quality management systems

• Experience working in a clinical laboratory regulated environment

• Knowledge of lean tools and root cause analysis methodologies

• Strong background in GMP manufacturing

• Project management skills

• Ability to work in a matrix organization

• High emotional intelligence with proven ability to set a course and bring his/her peers forward with them.

• Excellent communication skills to work as a leader, provide internal customer support, and influence other departments and individuals

• Excellent time management skills to support a fast paced working environment

• Strong leadership skills with demonstrated ability to effectively work across teams and functions

• Highly Preferred:

• Graduate degree in an engineering or scientific discipline

• Veeva experience

• Experience with Laboratory Information Management Systems (LIMS) and Manufacturing Management Systems (MES)

• Ability to travel up to 15% of the time

*For California based candidates;

The expected, full-time, annual base pay scale for this position is $110, 000.00 - $138, 000.00 . Actual base pay will consider skills, experience, and location.