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Validation Specialist , QA, Project Management, Technical Writing, CAPA, Biopharma at Apex Systems, Inc. in Woburn, MA

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Description

Sr. Validation Specialist, (QA, Biopharmaceuticals, Biologics, Technical Writing, cGMP, Non-conformance, CAPA, Change Control, Project Management)

SUMMARY: Sr. Biologics Validation Specialist QA with 8-10 yrs industry cGMP experience handling all validations. Ideal candidate would have science or Engineering experience/degree with at least 8 years’ experience in validation investigation within the Biopharma space.

  • Validation Specialist, GXP Compliance , Pharmaceutical, Technical Writing CSV, FDA, GMPs, 21CFR Part 11, USP 1058, IQ OQ PQ, Trace Matrix, Risk Assessment, Validation Plan, Design
  • Design, Author, and Execute Computerized System Validation (CSV), according to GAMP 5 guidance, especially on Analytical Laboratory Test Equipment and other Lab Information Systems (LIS)
  • Technical Writing of Validation Documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ, Trace Matrix, Validation Summary Report, SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents.

DUTIES:

  • Perform review, approval and tracking of cGMP validation documentation and including but not limited to Nonconformance, CAPAs, Change Control records
  • Project Management; supports development and ensure adherence to projects timelines
  • Validation investigation; ensures that deviations from established procedures are investigated and documented per procedures
  • Technical writing; ensures that documentation are complete, accurate, and documented according to written procedures and cGMP requirements
  • Collaborates cross functionally and provides validation/technical input as needed
  • Alerts of Quality, Compliance, Supply and safety risks
  • Completes required assigned training to permit execution of required tasks

QUALIFICATIONS:

  • Bachelors in a Science or Engineering and 8+ yrs. Biologics Validation and Project Management skills
  • At least 8 years’ experience in Validation Investigation within Biopharma
  • Must have 8+yrs Validation, 5yrs. Technical writing, 5+yrs Microsoft office
  • Requires 5 years of experience in Pharmaceutical and Validation
  • Knowledge in cGMP manufacturing and technical knowledge in validation of pharmaceutical Processes validation , Systems validation, Equipment validation.
  • Excellent writing and verbal communication skills along with strong Project Management skills.

PLEASE SEND RESUMES TO cbeltran@apexlifesciences.com , add “Sr. Validation Specialist, Biologics" to the subject, and call 732-636-1497 to discuss!

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 employeeservices@apexsystemsinc.com or 844-463-6178.


VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.

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