27 days old

Validation Specialist

Gannett Fleming, Inc.
Lancaster, Pennsylvania 17601
  • Job Code
    2019-6087
  • Job Type
    Employee
  • Job Status
    Full Time

We are looking for a Validation Specialist to support Life Sciences Group projects and our growing business in Gannett Fleming.  This position will be based out of the Lancaster (PA) office.  It is an excellent time to come join our team.

 

Responsibilities:

  • Author and execute CQV (Commissioning, Qualification, Validation) test scripts / protocols for facilities, utilities, automated equipment, and computerized systems with minimal supervision.
  • Author validation plans, risk assessments, requirement documents, traceability matrices, summary reports, and other supporting documentation for new and existing manufacturing equipment, processes, and products.
  • Develop Standard Operating Procedures (SOPs)and Work Instructions (WIs) for facilities, utilities, automated equipment, and computerized systems with minimal supervision
  • Specialized and demonstrated knowledge in the area of one or more of the following is required - computer system validation, automated equipment/systems qualification and validation, facilities and utilities commissioning and qualification, or primary and secondary packaging (strongly preferred).
  • Develop, oversee, and/or execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) documentation for automated manufacturing and packaging equipment/systems, building automation systems, or other suppliers/vendors at the customers' or vendors' sites.

Requirements

Minimum Qualifications

  • A four-year degree in a technical, manufacturing, or quality related field perferred
  • Excellent verbal and written communication skills required
  • Excellent attention to detail
  • Ability to handle multiple tasks, projects or assignments.
  • Demonstrated proficiency with Microsoft applications (Word, Excel, PowerPoint).
  • Must be able to work independently and to coordinate with team members in other offices
  • Preference given to candidates possessing two or more years experience working in the pharmaceutical, biotech, or medical device industries
  • Strong preference given to candidates with experience with the authoring and execution of CQV documentation including validation documentation, technical protocols and/or technical reports preferred.
  • Strong preference given to candidates with experience working in an FDA-regulated environment and working knowledge of FDA (and of other regulatory bodies) Regulations/Guidance, and Good Manufacturing Practices
  • Ability to travel to client locations in Eastern PA as projects assignments require approximately 50% of your time
  • Ability to travel internationally for one to two weeks per trip for equipment FAT; approximately 5% of your time
  • Ability to work flexible hours including evenings and weekends to meet business needs (occasionally).
  • Ability to pass background and drug/alcohol screenings by clients.

Categories

Posted: 2019-08-19 Expires: 2019-09-18

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Validation Specialist

Gannett Fleming, Inc.
Lancaster, Pennsylvania 17601

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