Validation Engineer jobs in Worcester, 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.
- 11 Days Ago
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...
- 20 Days Ago
Engineering - Engineer - Test Method Validation (Mid Level)
- Genesis10
-
Marlborough, MA
FULL_TIME
- Genesis10 is currently seeking a Engineer - Test Method Validation (Mid Level) with our client in the healthcare industry in their Marlborough, MA location. Hybrid Role: Onsite M,T,W Remote: Th, F. Jo...
- 29 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...
- 11 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...
- 13 Days Ago
Cleaning Validation Specialist
- Katalyst Healthcares & Life Sciences
-
Worcester, MA
FULL_TIME
- Responsibilities: Cleaning Validation Expertise: The primary responsibility of the Cleaning Validation Specialist is to develop, execute, and oversee cleaning validation protocols for pharmaceutical a...
- 1 Month Ago
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0 Validation Engineer jobs found in Worcester, MA area
Validation Engineer
- Ehub Global Inc
-
Providence, RI
- CSV Validation Engineer Location: Providence, RI/Cambridge, MA Duration: 6m+ Overview: This individual will be responsib...
- 4/18/2024 12:00:00 AM
Validation Engineer
- Ehub Global Inc
-
Providence, RI
- CSV Validation Engineer Location: Providence, RI/Cambridge, MA Duration: 6m+ Overview: This individual will be responsib...
- 4/18/2024 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...
- 4/17/2024 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 ...
- 4/17/2024 12:00:00 AM
Validation Engineer
- Katalyst Healthcares & Life Sciences
-
Norwood, MA
- Responsibilities: Strong knowledge/experience with LIMS (Laboratory Information Management System), Softmax , ELN (Elect...
- 4/16/2024 12:00:00 AM
Validation Engineer III
- Anika
-
Bedford, MA
- Summary of Primary Responsibilities: Leads start-up, commissioning, qualification, validation and revalidation projects ...
- 4/16/2024 12:00:00 AM
Validation Engineer III
- Anika
-
Bedford, MA
- Summary of Primary Responsibilities: Leads start-up, commissioning, qualification, validation and revalidation projects ...
- 4/16/2024 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 ...
- 4/16/2024 12:00:00 AM
About Worcester, Massachusetts
Worcester has a total area of 38.6 square miles (100 km2), 37.6 square miles (97 km2) of land and 1.0 square mile (2.6 km2) (roughly 2.59%) of water. Worcester is bordered by the towns of Auburn, Grafton, Holden, Leicester, Millbury, Paxton, Shrewsbury, and West Boylston.
Worcester is known as the Heart of the Commonwealth, because of its proximity to the center of Massachusetts. The city is about 40 miles (64 km) west of Boston, 50 miles (80 km) east of Springfield, and 38 miles (61 km) northwest of Providence, Rhode Island.
The Blackstone River forms in the center of Worcester by the conflue...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$58,944 to $78,737
Worcester, Massachusetts area prices
were up 1.6% from a year ago
were up 1.6% from a year ago
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