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engineer i, cqv, laboratory compliance, clinical biomarker laboratory.

• norwood , massachusetts

• posted july 30, 2024

job details

summary

• $45 - $50.32 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations architecture and engineering occupations

• reference48584

job details

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

location: Norwood, Massachusetts

job type: Contract

salary: $45.00 - 50.32 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

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.

• 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.

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.

skills: SOP, MS-Powerpoint, MS-Project, GLP (Good Laboratory Practice), GCP (Good Clinical Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.