• Contract
  • Hire
  • Lowell, MA

Website Agile Workplace Staffing

Agile is looking for a Validation Engineer in Lowell MA

This position is responsible for writing, implementing, analyzing results, and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. Develop and assess the following Quality System elements for process Validation including CAPAs and deviations. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validation studies and projects to enhance the manufacturing processes to compliantly achieve organizational goals.

What you will be doing

  1. Provide technical input to validation activities
  2. Represent process validation during equipment installations
  3. Support process validation Quality Systems
  4. Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices
  5. Participate in regulatory agency inspections for Process Validation
  6. Serve as one of the main points of contact in communication to customer whose equipment and processes you will be validating.
  7. Responsible for updating site Project Management and aiding in schedule and cost forecasting of validation activities.
  8. Complies with company, quality and safety standards, policies, and procedures
  9. Other duties as assigned.

What we require from you:

Bachelor’s degree Chemical/Biochemical/Bioprocess/Industrial/Mechanical Engineering, Chemistry, Biochemistry, or related field with 3 or more years relevant experience.

  1. Experience authoring and completing validation studies. Understanding of cGMP requirements for validation documentation. Demonstrate ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices
  2. Experience authorizing & building process validation studies for commercial GMP manufacturing processes.
  3. Experience with troubleshooting / problem-solving and risk assessment / mitigation
  4. Working knowledge of the science and technology for the major unit operations associated with manufacturing operations is considered a plus.

Working environment

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

 All Employees who are offered and accept this position will be required to pass a Criminal Background Check.

We are Committed to Your Success

We offer a competitive package, dynamic work environment, collaborative team, and space to learn, grow and thrive. Qualified applicants will receive consideration regarding race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, veteran status, or disabilities.

If you are a hardworking, driven professional looking for your next team. We are committed to employing a diverse workforce,  let’s start a conversation. Apply today!   


To apply, please visit the following URL:https://cats.agilewps.com/careers/index.php?m=careers&p=applyToJob&ID=1779→