Engineer, Laboratory Compliance, Clinical Biomarker

Engineer, CQV, Laboratory Compliance, Clinical Biomarker

$40-45 an hour

6 months, onsite Norwood MA

The Role

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.

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.

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

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

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.
• 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.
24 days ago