Sr. Validation Engineer - non CA in Warren, NJ at Apex Life Sciences

Date Posted: 11/10/2018

Job Snapshot

Job Description


Senior Validation Engineer:

Responsibilities:

  • Implements and maintains all validated computer systems in compliance with policies, guidelines and procedures. 
  • Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures. 
  • Executes equipment qualifications, validation protocols, and process improvement studies. 
  • Conducts investigations into qualification failures, develops and implements remediation plans 
  • Oversees vendors for qualification and metrology functions. 
  • Initiates, guides and reviews written procedures for calibration and preventive maintenance of stand-alone computerized systems 
  • Manages laboratory computer system implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. 
  • Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems to meet business needs in accordance with required schedules or dates. 
  • Assists facilities with new construction and relocation projects which involve computerized systems. 
  • Reviews all calibration, qualification and validation documentation for accuracy, completeness and compliance to the standards.
  • Provides technical knowledge and direction as Laboratory Systems Management site representative during interactions with all cross functional groups, as required. 
    Promotes and provides excellent customer service and support. 
  • Regularly reviews, prioritizes, coordinates and promptly responds to customer equipment qualification, system validation, and support requests. 
  • Provides technical support and guidance on calibration, equipment qualification and validations issues.

Requirements: 

  • Preferred BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent 
  • Minimum 3-6 years of experience in FDA-regulated GMP lab environment 
  • VERY IMPORTANT - Must have experience using or working with stand-alone computerized lab systems 
  • Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry 
  • ***Advanced knowledge of 21 CFR Part 11 compliance***
  • Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems 
  • Strong experience writing and executing system validation & equipment qualification documents 
  • Ability to interact effectively with laboratory personnel, QA, and Facilities groups 
  • Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization.
  • Extremely proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation 
  • Innate ability to learn new software as required for equipment qualification and system validations. 
  • Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met. 

For immediate consideration, please submit a current resume to Max Ames at mames@apexlifesciences.com and reference Job #902929

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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