6 Month Contract

Norwood, MA

PR: $45-50

Job Summary

The Engineer I, CQV (Commissioning, Qualification, and Validation) will be responsible for delivering commissioning, qualification, and validation activities ensuring equipment and systems remain in a qualified operational state of compliance within a GCLP/GLP Laboratory environment. This individual will collaborate closely with Lab Operations, Lab Compliance and R&D Quality to complete qualification activities. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment. This role will report to the Associate Director, Laboratory Compliance, Clinical Biomarker Laboratory. This is a non-remote position.

Job Responsibilities

• Execute commissioning, qualification, and validation activities to maintain compliance with GCLP guidelines and GLP regulations.
• Author and execute design, commissioning, qualification, and validation documentation and support records to certify compliance with specifications and procedures.
• Ensure timely resolution of documentation compliance and quality system issues.
• Investigate deviations related to qualification and validation activities
• Participate in cross-functional teams to meet project timelines and business needs while adhering to regulatory requirements.
• Ensure Standard Operating Procedures (SOPs) and procedures are created, understood, and followed.
• Participate in Moderna training to support CQV requirements.

Education & Qualifications

• B.S. in engineering, science, or an equivalent technical field.
• Minimum of one (1) year of relevant experience in a GCLP/GLP environment is desirable.
• Understanding of commissioning, qualification, and validation principles.
• Strong technical documentation generation and review skills, ensuring content is technically sound and adheres to applicable site procedures.
• Ability to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.
• Excellent interpersonal and communication skills (verbal and written), with the ability to present work to peers and cross-functional managers and influence leadership decisions.
• Ability to interact well with other groups and take ownership of and follow through on assignments.
• Ability to represent the company's interests, objectives, and policies in a professional and responsible manner.
• Meticulous attention to detail, organizational ability, clinical judgment, and good communication skills.
• High proficiency in MS PowerPoint and MS Project, excellent writing skills, organizational skills, and attention to detail.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.