RockyMountRecruiter
the smart solution for Rocky Mount jobs

Validation Engineer II

Company: TalentBurst
Location: Rocky Mount
Posted on: May 11, 2019

Job Description:

Job Description

Job Description: Lab Instrument Validation:
QUALIFICATIONS

**** HM wants you to focus on the top 3 bullet points. If you have any questions or are unsure before submitting please send resume to me.

\"" 3-5 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 validating various laboratory instrument systems (e.g. PerkinElmer AA, FT-IR, Climet CI-150t, IC, Agilent ICP-MS, Instron 5965, Keyence IM-7030, SmartScope Flash 500, TOC, UV_Vis)
\"" Demonstrated expertise in identifying as well as formulating procedural controls to compensate for shortcomings in the system\u0019s data integrity and FDA 21 CFR Part 11 controls.
\"" Demonstrated understanding of global regulations on data integrity, FDA 21 CFR Part 11 and validation/qualification requirements.
\"" Excellent attention to detail and working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
\"" Bachelor\u0019s degree in a science or engineering related discipline with knowledge of quality operations laboratory processes.
\"" Ability to manage multiple activities and constantly change priorities.
\"" 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.)
\"" Strong critical thinking and problem solving skills.

ROLE RESPONSIBILITIES
\"" Serves as validation representative for laboratory instruments and partners 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 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\u0019s adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, 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 workarounds/strategies 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.
\"" Previous experience with Trackwise PR/CAPA systems preferred.
\"" Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.
\"" All other duties as assigned.

Top 5 Skills -Requirement:

we are looking for is someone who has the experience with the following:

1. Validation of laboratory instruments including those with computer system attached for instrument control (i.e. AA, FT-IR, ICP-MS, TOC, UV_Vis)
2. Experience with configuring, testing and validating the laboratory systems to demonstrate compliance with 21 CFR Part 11/Annex 11 as well as proposing procedural controls if the system is unable to fully meet the requirements
3. Hands on experience operating the instrument systems to be able to write test scripts to demonstrate the essence of the Part 11 regulations which is to ensure that electronic records and signatures are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. As such the electronic records should not be susceptible to unauthorized access, alteration/modification, deletion, or other methods of falsification and the audit trail must capture changes. These records need to be accurate and be accessible/available for the duration of data retention period in case it is needed for regulatory or other audits.
4. Must be able to multi-task \u0013 new/multiple projects will be thrown at the worker constantly, must be able to handle all of them.
5. Detail oriented is a must!

Resumes must be in depth and detailed, if lab experience is listed they MUST provide specific details. All experience must be recent within last 5 years
Position Comments visible to MSP and Supplier:

Company Description:

TalentBurst is an award winning IT, Accounting & Finance staffing firm headquartered in Boston with offices in San Francisco, Miami, Milwaukee, Toronto, Bangalore, and Gurgaon. Our clients include the leading social media, technology, banks, utilities, pharmaceutical, and biotech companies.We work with 75 of the Fortune 500 companies. Our recruiting team is one of the most successful in the industry and has a strong reputation for treating our employees well and helping you find your next dream project.BenefitsAt TalentBurst, one of our founding principles has been to provide our employees with the best benefits available. Benefits we have available include:--- Health, Dental, and Vision Plan--- 401(k) Plan--- Life Insurance--- Immigration assistance--- Credit Union Membership--- Direct Deposit--- Vacation pay (only for FTEs)

Keywords: TalentBurst, Rocky Mount , Validation Engineer II, Other , 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 Other Jobs


Law Enforcement Transcriber
Description: Individuals who can transcribe audio content of criminal investigations, internal affairs, and patrol reports. You must have prior experience transcribing for a law enforcement agency
Company: Mommy Jobs Online
Location: Chapel Hill
Posted on: 05/21/2019

Email Marketing Specialist- (Contract)
Description: Mommy Jobs Online is now recruiting remote contractors to become an agent. Job Details: You will post our job ads, send email correspondences
Company: Mommy Jobs Online
Location: Wilson
Posted on: 05/21/2019

Computer Programmer
Description: Revature is the fastest growing employer of emerging technology talent in the US and we are currently looking to hire over 100 new Software Engineers.Our Software Engineers design, analyze and build next-gen (more...)
Company: Revature
Location: Rocky Mount
Posted on: 05/21/2019


Appointment Setting Work from Home
Description: Are you seeking a career that will allow you the ability to work from home with a greater earning potential TeleReach Corporate offers both. As a Business Development Representative with TeleReach, you (more...)
Company: TeleReach Corporate
Location: Wilson
Posted on: 05/21/2019

OT - Wilson, NC
Description: We need a OT traveler for a skilled nursing facility, must have 1 year of SNF, and geriatric experience. Hours are M-F with a guarantee of 40 hours.This
Company: Prime HealthCare Staffing
Location: Wilson
Posted on: 05/21/2019

Graduates - Teach English In China. Free Flights
Description: About EF English First br br EF English First is the world's leading privately owned education company. Founded in 1965, EF operates in over 50 countries around the world. We have vacancies for english (more...)
Company: EF English First
Location: Rocky Mount
Posted on: 05/21/2019

Medical Transcriptionist
Description: Medical Transcriptionist MT Desk is seeking a multi-specialty medical transcriptionist to work PT or FT remotely for a hospital
Company: Mommy Jobs Online
Location: Rocky Mount
Posted on: 05/21/2019

Email Marketing Specialist - (Contract)
Description: Mommy Jobs Online is now recruiting remote contractors to become an agent. Job Details: You will post our job ads, send email correspondences
Company: Mommy Jobs Online
Location: Rocky Mount
Posted on: 05/21/2019

Bid On Local Landscaping Jobs - Reach New Customers In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Rocky Mount
Posted on: 05/21/2019

Healthcare Reps.
Description: Our Healthcare Company is looking for individuals and leaders to help expand business in the local area. We offer
Company: IBO
Location: Chapel Hill
Posted on: 05/21/2019

Log In or Create An Account

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

Rocky Mount RSS job feeds