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.
