Validation and Commissioning Engineer

job summary:
Commissioning, Qualification, and Validation Engineer needed for an immediate 4-month contract in the Canton, MA area!

In this role, you will execute CQV documentation, maintain compliance with GCLP guidelines and GLP regulations, and work in harmony with cross-functional teams. The overview of this project involves relocating approximately 36 pieces of equipment from one location to another. This will obviously involve the proper de-commissioning and re-commissioning process for that equipment.

This position is responsible for providing quality oversight, guidance, and decision-making for Quality Control (QC) equipment moves, qualification activities and decommissioning activities across the two sites. Your detail in following all GxP regulations, guidelines, and company policies and documentation review will be key to the success of this project. The right person will be experienced, confident and will possess awesome team and communication skills with a drive for success!

Does this sound like you? Apply now for immediate consideration!

location: Canton, Massachusetts
job type: Contract
salary: $65 - 70 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.

Requirements

• BS in engineering, Bio-science, or an equivalent technical field.

• 5+ years experience in CQV activities within the biotechnology/biopharmaceutical industry, or other regulated industry within a GMP environment.

• Understanding of commissioning, qualification, and validation principles.

• Proven technical documentation generation and review skills, ensuring content is technically sound and adheres to applicable site procedures with meticulous attention to detail

• Excellent interpersonal and communication skills (verbal and written), with the ability to present work to peers and cross-functional managers and influence leadership decisions.

• Knowledge of FDA, EU, ICH guidelines, and relevant regulations.

• Proficiency in Kneat swr. or similar, 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:

• Good Manufacturing Process
• Biomedical
• Good Lab Practices GLP
• GCLP Guidlines
• CQV Documentation
• SOP
• Documentation Control
• Commissioning
• Process Validation
  
  
  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 View email address on 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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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.