Commissioning, Qualification, and Validation Engineer needed for an immediate long term project needed in the Canton, MA area!
The right person will have a passion in bio technology delivering CQV activities ensuring equipment and systems are operational and compliant at all times. Our client is looking for a sharp engineer with a biotech passion who has a full understanding of GMP, GCLP guidelines and GLP regulations.
You don't need a ton of experience! Just a year plus of relevant experience in a GCLP/GLP or CLIA/CAP environment is desirable.
Some of the tasks you will be performing are the execution of CQV documentation, maintaining compliance with GCLP guidelines and GLP regulations while working in harmony with cross functional teams. This person will have a knack for details and be able to address & resolve any issues that may arise.
This person must possess awesome team and communication skills with a drive for success! Sound like you? Apply now for immediate consideration!
location: Norwood, Massachusetts
job type: Contract
salary: $48 - 50 per hour
work hours: 8am to 4pm
education: Bachelors
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.
- 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.
- Proven 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.
- 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.
qualifications:
- Experience level: Experienced
- Minimum 3 years of experience
- Education: Bachelors (required)
skills:
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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
