Validation Engineer jobs in Fitchburg, MA
Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Recently Added Validation Engineer jobs
Validation Engineer
- Katalyst Healthcares & Life Sciences
-
Hopkinton, MA
FULL_TIME
-
Roles & Responsibilities:
Perform equipment and system validations.
Develop, review, and approve accurate documentation, as required in cGMP operations.
Provide responsive customer support with emphasis on customer satisfaction.
Work in a collaborative team environment and interact with other support groups such as Manufacturing, PD, QC, MS&T, and Quality Assurance.
Assist with HSE, Qualification and Maintenance activities as needed.
Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing commissioning/qualification activities.
Assist with drafting of accurate commissioning/qualification procedures and training documents/tools
Ensure assigned re-qualifications (RQs) are completed on-time.
Provide QC lab validation review (LEQ) as required.
Review Validation protocols, reports, data, plans, change controls, etc., as required.
Provide technical assistance to less experienced technicians/engineers.
Work as part of a team to ensure that commissioning/qualification activities are completed on-time and correctly.
Work as part of a multi-disciplinary team for Commissioning/Qualification using a science and risk-based approach.
Manage medium to large size commissioning/qualification projects and change control-based qualification activities.
Develop Validation Plans for validation projects.
Perform SOP revision, review, and approval.
Generate deviations, CAPAs, perform investigations and root cause analysis.
Work with Quality Assurance on the revision of validation documents (e.g. Master Plans, Requalification program)
Present and defend validation studies during regulatory inspections and internal audits.
Education & Experience:
Bachelor's degree (or equivalent) in engineering/science
4 years' experience hands-on experience in Biotech, Pharmaceuticals or Medical Device operations, including protocol development and field execution.
Working knowledge of Validation Lifecycle Approach (DQ, IQ, OQ, PQ, PV, and RQ)
Knowledge of applicable US and worldwide regulatory requirements (e.g. GMP, GDP, ICH)
Ability to develop and/or review protocols using design documents and user requirements.
Experience with chamber temperature mapping, tubing welders, and Biosafety cabinets are a plus.
Ability to manage medium to large size commissioning/qualification projects.
Ability to perform thorough statistical analysis of validation rest results.
Excellent technical writing and verbal communication skills
Ability to Investigation/troubleshooting system/testing failures
Ability to read/interpret engineering drawings (e.g. P&IDs, PFD's)
Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio.
- 17 Days Ago
Validation Test Engineer
- Actalent
-
Westborough, MA
OTHER
- Key Responsibilities:• Working collaboratively with multiple stakeholders such as R&D, manufacturing, supply chain, and quality to determine key design considerations for test equipment design, fabric...
- Just Posted
NPI Commissioning and Validation Engineer, Deployment Readiness
- Amazon
-
Westborough, MA
FULL_TIME
- DESCRIPTIONAmazon is building the next generation software, hardware, and processes that will run the global network of fulfillment centers that move many millions of units of inventory, and ensure th...
- 25 Days Ago
Associate Director Process Validation
- EasyHiring
-
Marlborough, MA
FULL_TIME
- We are a recruiting company EasyHiring, which is looking for candidates for our partners for a position Associate Director Process Validation in Marlborough, MA to work in the Devens, MA.Position Summ...
- 17 Days Ago
Associate Director Process Validation
- EasyHiring
-
Groton, MA
FULL_TIME
- We are a recruiting company EasyHiring, which is looking for candidates for our partners for a position Associate Director Process Validation in Groton, MA to work in the Devens, MA.Position SummaryCo...
- 18 Days Ago
Cleaning Validation Specialist
- Baanyan Software Services, Inc.
-
Worcester, MA
FULL_TIME
- Job DetailsJob Description:We are seeking a skilled Cleaning Validation Specialist to join our team in Worcester, MA. The ideal candidate will have 5-10 years of experience in cleaning validation, wit...
- Just Posted
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0 Validation Engineer jobs found in Fitchburg, MA area
Verification Validation Engineer
- Sunrise Systems, Inc.
-
Andover, MA
- Our client, a leading medical devices company, is looking for a Verification & Validation Engineer. This is for an initi...
- 4/23/2024 12:00:00 AM
Senior Validation Engineer
- Talent Groups
-
Marlborough, MA
- Job Role: Automation Verification Lead Engineer Location: Marlborough MA 01752 (Onsite or Hybrid or Remote): Onsite (Rel...
- 4/23/2024 12:00:00 AM
Senior Validation Engineer
- a Medical Devices company in MA
-
Bedford, MA
- Senior Validation Engineer RESPONSIBILITIES Leading start-up, commissioning, qualification, validation and revalidation ...
- 4/22/2024 12:00:00 AM
Validation Engineer
- Novozen Healthcare LLC
-
Westford, MA
- Responsibilities: · You will directly be supporting the manufacturing process validation team and conducts risk assessme...
- 4/22/2024 12:00:00 AM
Validation Engineer III
- Anika
-
Bedford, MA
- Summary of Primary Responsibilities: Leads start-up, commissioning, qualification, validation and revalidation projects ...
- 4/21/2024 12:00:00 AM
Senior Validation Engineer
- Premier Life Sciences LLC
-
Framingham, MA
- Not For C2C Candidates Role: Commissioning Validation Engineer Location: Framingham MA (Now) we have more locations avai...
- 4/21/2024 12:00:00 AM
Validation Engineer
- Novozen Healthcare Llc
-
Westford, MA
- Responsibilities: You will directly be supporting the manufacturing process validation team and conducts risk assessment...
- 4/20/2024 12:00:00 AM
Principal Commissioning/Validation Engineer III
- TalentBurst, an Inc 5000 company
-
Framingham, MA
- Industry: Biotechnology Position: Principal Commissioning/Validation Engineer III Location: Framingham, MA - 01701 Durat...
- 4/20/2024 12:00:00 AM
About Fitchburg, Massachusetts
Fitchburg is the third largest city in Worcester County, Massachusetts, United States. The population was 40,318 at the 2010 census. Fitchburg is home to Fitchburg State University as well as 17 public and private elementary and high schools.
Fitchburg is located at 42°34′43″N 71°48′12″W / 42.57861°N 71.80333°W / 42.57861; -71.80333 (42.578689, −71.803383).
According to the United States Census Bureau, the city has a total area of 28.1 square miles (73 km2), of which 27.8 square miles (72 km2) is land and 0.3 square miles (0.78 km2), or 1.07%, is water. The city is drained by the Nashua Riv...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$59,559 to $79,558
Fitchburg, Massachusetts area prices
were up 1.6% from a year ago
were up 1.6% from a year ago
What does a Validation Engineer do?
Validation Engineer in Fayetteville, AR
Guide the recruiter to the conclusion that you are the best candidate for the validation engineer job.
March 03, 2020
Validation Engineer in Bradenton, FL
Have you worked as a System Validation Engineer? Help other job seekers by rating your experience as a System Validation Engineer.
February 29, 2020
Validation Engineer in Wilmington, NC
In this job description guide, you will find out what do Validation Engineers do and what is their typical work day like.
February 16, 2020