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MV03-030124 Specialist QA [12 hours shift]

Department: Field - FG
Location: Juncos, 077

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Sr. Engineer
  • 12 hrs. shift AM or PM, including weekends and Holidays.
    • The rotations runs Shifts A1 / A2 / B1 and B2.
    • A1 and B1 Day Shifts 5am-5:30pm
    • A2 and B2 Night Shifts 5pm-5:30am

Responsibilities:

  • You will perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation’s, CAPAs, and validations.
  • Actively engage in Continues Improvement initiatives, programs and projects
  • Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
  • Certify that deviations from established procedures are investigated and documented per procedures.
  • Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • To be successful, you will require strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures.
  • Strategic advisor to senior management of quality, compliance, supply and safety risks.
  • Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed.
  • Accountable for assigned training adherence to permit execution of required tasks.
  • Champion Continuous Improvement initiatives and projects.
  • Provides support and oversight of New Product Introduction (NPI).
  • Validated expertise in Quality Systems such as Non-Conformance, CAPA, and Change Control.
  • Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency).
  • Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.
  • Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
  • Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products.

General Description:

  • Review and approve product MPs.
  • Approve process validation protocols and reports for manufacturing processes.
  • Request Quality on incident triage team.
  • Approve Environmental Characterization reports.
  • Release of sanitary utility systems.
  • Approve planned incidents.
  • Represent QA on NPI team.
  • Lead investigations.
  • Lead site audits.
  • Own site quality program procedures.
  • Designee for QA manager on local CCRB.
  • Review Risk Assessments.
  • Support Automation activities.
  • Support facilities and environmental programs.
  • Review and approve Work Orders.
  • Review and approve EMS/BMS alarms.
  • Approve NC investigations and CAPA records.
  • Approve change controls.
  • Provide lot disposition and authorize lots for shipment.


Education:

  • Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience.

Skills:

  • Project management skills.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Initiate and lead cross functional teams.
  • Enhanced skills in leading, influencing and negotiating.
  • Strong knowledge in area of expertise.
  • Collaborate and coordinate with higher level outside resources.
  • Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
  • Demonstrate ability to interact with regulatory agencies.
  • Strong word processing, presentation, database and spreadsheet application skills.
  • Strong communication (both written and oral), facilitation and presentation skills.
  • Strong skill in working independently and to effectively interact with various levels.
  • Advanced data trending and evaluation.
  • Ability to evaluate compliance issues.

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