RockyMountRecruiter Since 2001
the smart solution for Rocky Mount jobs

Validation Engineer III

Company: eclaro
Location: Rocky Mount
Posted on: June 28, 2019

Job Description:

Eclaro s client is among the world s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you re up to the challenge, then take a chance at this rewarding opportunity Responsibilities Serving as validation representative for laboratory instruments and partnering with the laboratories, Quality System Administrators, Business Technology, Instrumentation and Quality Engineering on implementing new instruments at the site Initiates and leads risk assessment, gap analysis and deviation management for commissioning of, changes to or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Control laboratories Authors cGMP risk assessments, user requirements functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs Ensures lab instrument s adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11210211, EU Annex 11, MHRA guidelines Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence For systems found unable to fully comply, formulate workaroundsstrategies with core stake holders to mitigate the gaps Assists the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and setting up preventive maintenance plans Completes periodic reviews of laboratory instruments and associated instrument control software with focus on change control, deviation investigations and CAPA to ensure compliance and validated state of the instrument Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed May supervise andor mentor junior level engineers Required Experience 5-7 years of experience in the validation of laboratory instruments including those with computerized systems attached in a biotechnology or pharmaceutical cGMP manufacturing environment Hands on experience operatingvalidating various laboratory instrument systems (e.g. AA, FT-IR, IC, ICP-MS, TOC, UVVis) Demonstrated expertise in identifying as well as formulating procedural controls to compensate for shortcomings in the system s data integrity and FDA 21 CFR Part 11 controls 3-5 years of experience in performing periodic review of laboratory instruments including those with computerized systems Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validationqualification requirements Bachelor s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes Exposure to lab operations and scientific processes associated as well as familiarity with a variety of laboratory instruments with various areas (Chemistry, Micro, Biological, EM etc.) Required Skills Excellent attention to detail and working knowledge of FDA RegulationsGuidance, and Good Manufacturing Practices Ability to manage multiple activities and constantly change priorities Strong critical thinking and problem solving skills Validation of laboratory instruments including those with computer system attached for instrument control (i.e. AA, FT-IR, ICP-MS, TOC, UVVis) Experience to configure, test and validate the system to demonstrate compliance with 21 CFR Part 11Annex 11 as well as proposing procedural controls if the system is unable to fully meet the requirements Must be able to multi-task - new projects will thrown at the worker constantly, must be able to handle all of them Detail oriented If hired, you will enjoy the following Eclaro Benefits 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental Vision Insurance through Eclaro

Keywords: eclaro, Rocky Mount , Validation Engineer III, Engineering , Rocky Mount, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Engineering Jobs


91B Light-Wheel Vehicle Mechanic
Description: 91B Light-Wheel Vehicle Mechanic Job ID: 1080246 Job Views: 25 Location: DURHAM, North Carolina, United States ZIP Code: 27704 Job Category: Mechanic and Maintenance Posted: 07.19.2019 Age Requirements: (more...)
Company: Army National Guard
Location: Durham
Posted on: 07/24/2019

Building Envelope Senior Engineer/Architect
Description: Job Description Terracon's Raleigh, NC office is looking for a senior-level engineer or architect to join our Building Enclosure consulting team. Although this position will be focused on Building Enclosure (more...)
Company: Terracon
Location: Raleigh
Posted on: 07/24/2019

Senior Field Application Engineer
Description: DNA Group, Inc., a solutions provider disciplined in Contract Manufacturing, HMI, Connectivity and Smart Illumination, located in Raleigh,
Company: DNA Group, Inc.
Location: Raleigh
Posted on: 07/24/2019


DynaTrace Performance Engineer
Description: One of our clients is looking for a DynaTrace Performance Engineer based on the following skills Minimum Requirement Experience designing, configuring, and implementing complex Dynatrace deep diagnostics (more...)
Company: Digitek Software, Inc.
Location: Raleigh
Posted on: 07/24/2019

Staff QA Engineer
Description: Job DescriptionStaff QA Engineer br br When you re part of the team at Thermo Fisher Scientific, you ll do important work, like helping customers in finding cures for cancer, protecting the environment (more...)
Company: Thermo Fisher Scientific
Location: Greenville
Posted on: 07/24/2019

Lead Data Engineer
Description: Job Location: United States : North Carolina : Cary br Role Value Proposition br MetLife's Employee Experience organization is seeking an experienced Data Engineer to evolve the Employee Experience (more...)
Company: MetLife
Location: Cary
Posted on: 07/24/2019

Turnover/Redecoration Maintenance Technician
Description: Turnover/Redecoration Maintenance Technician Job Responsibilities: Lake in the Pines Apartments is currently seeking a hardworking, self-motivated, Turnover Maintenance Technician to join our successful (more...)
Company: Edward Rose & Sons
Location: Fayetteville
Posted on: 07/24/2019

Service Technician
Description: SummaryTechnicians will be held to a high standard of service, ICEE has a commitment to success: to our customers, partners, and employees. Technicians are required to service all ICEE and restaurant (more...)
Company: The ICEE Company
Location: Raleigh
Posted on: 07/24/2019

Senior Security Engineer - Endpoint Protection
Description: Senior Security Engineer - Endpoint Protection Job Location: Cary NCRole Value Proposition:As part of the Global Technology and Operations organization the Senior Security Engineer is responsible for (more...)
Company: Met Life
Location: Cary
Posted on: 07/24/2019

Senior Middleware Engineer
Description: Senior Middleware Engineer Job Location: Cary, NC Role Value Proposition: Senior Engineer's role as part of the Shared Application Platform Engineering team is to provide for the enterprise configuration (more...)
Company: MetLife
Location: Cary
Posted on: 07/24/2019

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Rocky Mount RSS job feeds