Oxford Immunotec, Inc.

Validation Engineer

US-MA-Norwood
4 weeks ago
ID
2017-1797
# of Openings
1
Department
Norwood Lab

Overview

The Validation Engineer will be responsible for the leading all validation activities for Oxford Immunotec’s Norwood site. The Validation Engineer will be responsible for writing and executing validation plans, including IQ, OQ, and PQ for laboratory equipment, processes, and facility utilities.

Responsibilities

  • Develop Validation Master Plans for laboratory and facility systems. 
  • Write and execute (or oversee) Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
  • Perform GMP assessments and functional risk assessments to determine the extent of validation of a given application/change would require.
  • Designs and implements validation test plans and analyzes results. Collects and reviews validation data and generates exception reports as needed. Ensures validation efforts are conducted in an appropriate and timely manner.
  • Author and complete comprehensive documentation in support of FDA submissions, supplements, and ongoing compliance.
  • Monitors new equipment and process design plans to ensure proper and sufficient validation plans are created. 
  • Coordinates with Quality, Regulatory, R&D, Laboratory Operations, and Engineering departments to assure coordination and consistency.
  • Conducts risk assessments as required by validation plans and thoroughly documents.
  • Participates in BLA supplement project teams, providing input on timelines, inputs, and requirements for successful and timely validations. 
  • Partners with QA to ensure that the Blood Donor Screening and Manufacturing operations are in compliance. 
  • Must carry out all their activities in compliance with the company’s Quality ethos, the requirements of the company’s Quality Management System and in compliance with the requirements of regulations governing laboratory testing and manufacturing (e.g. FDA, HIPAA, CLIA and CAP).
  • Work to Oxford Immunotec Company Values at all times.
  • Aware of Health & Safety policies and laboratory safety rules.

Qualifications

  • Experience writing and performing Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) on facilities, general laboratory equipment (liquid handlers, centrifuges, incubators, etc.) as well as specialized instrumentation.
  • Working knowledge of 21CFR 820 and 21CFR 606 is desirable.
  • Experience with Computer System Validation (CSV) including 21CFR part 11 compliance.
  • Extensive knowledge in cGMP and GDP. 
  • Demonstrates the highest level of ethics and integrity.
  • Ability to work independently and demonstrate a high degree of personal & professional initiative.
  • Problem solving ability - able to develop creative, practical solutions that meet business objectives.
  • Excellent time management skills; able to manage multiple competing priorities simultaneously.
  • Excellent verbal and written communication skills.
  • Proficient in Microsoft Office Programs.

 

EDUCATIONAL REQUIREMENTS & EXPERIENCE:

  • 7 or more years of experience in a validation engineering role.
  • Bachelor’s degree in Engineering or Life Sciences.

 

PHYSICAL DEMANDS:
The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

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