Validation Engineer

Location
Allentown, PA
Salary
Competitive
Posted
August 17 2017
Ref
53820BR
Position Type
Full Time
Job Description

Responsibilities:

  • Generating, executing, and reviewing protocols for controlled temperature units and packaging equipment.
  • Manage and maintain all Refrigerators, Freezers (CTUs) and Walk-In Cold Rooms/ Warehouse Storage Facilities within a proper validated state according to FCS standards.
  • Demonstrate and promote the company vision
  • Apply Good Manufacturing Principles in all areas of responsibility
  • Lead and further develop the Engineering Validation Department in conjunction with Manager, Validation Engineering
  • Plan and formulate aspects of engineering projects such as objective or purpose of project, applications that can be utilized from findings, costs of projects, and equipment and human resource requirements
  • Develop, procure, and implement new technologies and innovations either through internal channels and development and/or use of outside technologies and suppliers. Modify existing processes, improve techniques and develop test procedures
  • Maintain FCS validation methodology in accordance with applicable Quality/Regulatory requirements and industry best practices
  • Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials and facilities
  • Perform technical reviews and interpret data for accuracy of equipment/process performance for completed validations/revalidations
  • Author SOPs related to validation/re-validation activities
  • Represent validation in cross-functional meetings/projects as required
  • Ensure and/or execute proper calibration and maintenance of test equipment used for validation/revalidation of equipment and processes
  • Assist with identification and execution of Master Validation Plan (MVP) as required
  • Work closely with engineering to coordinate and execute Factory Acceptance Testing (FAT) activities and protocols
  • Provide constant communications with all affected departments and personnel regarding validation activities
  • Author, execute, perform, summarize, qualification and validation activities, IQ, OQ, PQ, PV, CSV
  • Conduct root cause analysis and deviation resolution for validation exceptions
  • Perform/conduct special projects assigned by management
  • Conducts all activities in a safe and efficient manner
  • Other duties may be assigned to meet business needs

Minimum Qualifications:

  • A four year, Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline and 2 or more years of validation experience in a regulated industry or equivalent validation experience including pharmaceutical packaging or cGMP experience.
  • Must provide direction to team and external department related functions and activities
  • Must have strong interpersonal skills
  • Must have strong analytical skills
  • Must be able to multitask and respond to shifting priorities
  • Must be proficient with computer software (MS Office) and have expertise with spreadsheets
  • Must have good communication skills, both written and verbal
  • Must have prior mechanical and process equipment experience
  • Must be results oriented

Preferred Qualifications:

  • Experience in Lean Manufacturing, Six Sigma and PPI

Ability and/or Skills:

  • Must provide direction to team and external department related functions and activities
  • Must have the ability and desire to interact with people
  • Must have strong analytical skills
  • Must be able to multitask and respond to shifting priorities.
  • Must be proficient with computer software (MS Office) and have expertise with spreadsheets
  • Must have good communication skills, both written and verbal
  • Must be detail oriented

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story

to tell. Join us and contribute to our singular mission—enabling our customers to make the

world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate

on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin,

protected veteran status, disability or any other legally protected status.




    Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.