GRAIL, Inc.
Process Engineer Summer Internship
GRAIL, Inc., Durham, North Carolina, United States, 27703
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.The Process Engineer Intern- Compliance will assist in the planning, development, improvement, organization, and implementation of the Equipment lifecycle program according to multiple regulatory bodies.
You will work alongside the engineering and quality team to reduce quality defects in our business and processes by ensuring documents such as work instructions, Standard Operating Procedures (SOPs), ensuring qualification protocols are technically accurate and compliant with industry standards and regulatory requirements.You will be expected to be onsite in Durham NC with our team 5 days a week during your internship. Start date is June 3, end date is Aug 16. There is a one week unpaid summer break July 1-5th.
You Will:
Assist with the development and implementation of engineering documentation including work instructions, guidelines, verifications, and standard operating procedures (SOPs) to ensure compliance with SOX, CLIA/CAP, FDA 21 CFR part 820, ISO 13485, IVDR requirements.Work closely with a cross functional team to address and resolve equipment documentation issues ensuring procedures clear, effective and adhere to GRAIL QMS.Collaborate with validation engineers to draft, review and execute equipment qualification
protocols.Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process.Support the planning and execution of qualification activities ensuring compliance with established procedures and guidelines.Participate and adhere to GRAIL’s policies and guidelines.Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process.Work closely with Compliance, Engineering, Quality and Regulatory to implement and follow the required policies and procedures for the lifecycle of equipments.Learn and have fun!Your Background Should Include:
Current enrollment in an engineering or science-related bachelor degree programStrong problem-solving skillsExcellent communication skills to work as a leader, provide internal customer support, and influence other departments and individualsExcellent time management skills to support a fast-paced working environmentBasic industrial, electrical, and mechanical knowledgeFamiliarity of systems infrastructureStrong writing and editing skills, with the ability to write clearly and conciselyAbility to work in a matrix organizationGood emotional intelligence with proven ability to set a course and bring his/her peers forward with them
Preferred:
Experience working in a clinical laboratory regulated environmentKnowledge of lean tools and root cause analysis methodologiesBackground in GMP manufacturing
Physical Demands/Working Environment:
Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear.Must regularly lift and / or move up to 10 pounds.Frequently lift and/or move up to 25 pounds.Occasionally lift and/or move up to 50 pounds.Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.
You will work alongside the engineering and quality team to reduce quality defects in our business and processes by ensuring documents such as work instructions, Standard Operating Procedures (SOPs), ensuring qualification protocols are technically accurate and compliant with industry standards and regulatory requirements.You will be expected to be onsite in Durham NC with our team 5 days a week during your internship. Start date is June 3, end date is Aug 16. There is a one week unpaid summer break July 1-5th.
You Will:
Assist with the development and implementation of engineering documentation including work instructions, guidelines, verifications, and standard operating procedures (SOPs) to ensure compliance with SOX, CLIA/CAP, FDA 21 CFR part 820, ISO 13485, IVDR requirements.Work closely with a cross functional team to address and resolve equipment documentation issues ensuring procedures clear, effective and adhere to GRAIL QMS.Collaborate with validation engineers to draft, review and execute equipment qualification
protocols.Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process.Support the planning and execution of qualification activities ensuring compliance with established procedures and guidelines.Participate and adhere to GRAIL’s policies and guidelines.Recommend and implement changes to ensure ongoing high-quality and efficient engineering operations procedures as part of the continuous improvement process.Work closely with Compliance, Engineering, Quality and Regulatory to implement and follow the required policies and procedures for the lifecycle of equipments.Learn and have fun!Your Background Should Include:
Current enrollment in an engineering or science-related bachelor degree programStrong problem-solving skillsExcellent communication skills to work as a leader, provide internal customer support, and influence other departments and individualsExcellent time management skills to support a fast-paced working environmentBasic industrial, electrical, and mechanical knowledgeFamiliarity of systems infrastructureStrong writing and editing skills, with the ability to write clearly and conciselyAbility to work in a matrix organizationGood emotional intelligence with proven ability to set a course and bring his/her peers forward with them
Preferred:
Experience working in a clinical laboratory regulated environmentKnowledge of lean tools and root cause analysis methodologiesBackground in GMP manufacturing
Physical Demands/Working Environment:
Regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear.Must regularly lift and / or move up to 10 pounds.Frequently lift and/or move up to 25 pounds.Occasionally lift and/or move up to 50 pounds.Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.