Commissioning, Qualification, and Validation

Engineer I, CQV, Laboratory Compliance, Clinical Biomarker Laboratory

Norwood, MA

Duration: 6-month contract

100% onsite – no exceptions

Must-have experience in GCLP/GLP or CLIA/CAP environment.

Must-have experience with the qualification of equipment & instruments

This person will be managing a large amount of paperwork that needs to go through the system and will be driving the qualification process.

Hiring manager suggests that this person is somebody coming from an operations position or lab facilities type team, could have a CQV title or, instrument validation or equipment validation

Here’s What You’ll Do

• 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.

Here’s What You’ll Need (Minimum Qualifications)

• Minimum of one (1) year of relevant experience in a GCLP/GLP or CLIA/CAP environment is desirable.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• B.S. in engineering, science, or an equivalent technical field.
• 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.