BostonRecruiter Since 2001
the smart solution for Boston jobs

Validation Engineer

Company: Yoh, A Day & Zimmermann Company
Location: Boston
Posted on: April 10, 2021

Job Description:

Temporary Validation Engineer

Job Description

Provides support in the areas of commissioning and qualification of facilities, equipment, laboratory, utilities and equipment. Expected to work independently with minimal guidance and demonstrate the ability to multi-task, problem solve, and communicate effectively and efficiently in a dynamic and challenging environment.


Author/Revise Validation SOP's for the PVD and Cambridge Sites.
Support harmonization of validation program at Cambridge and PVD with Vertex SOPs.
Assist in the investigation and remediation of Quality Events related to qualified equipment.
Assist in managing the Requalification schedule of CAMB & PVD equipment
Review lifecycle documents such as Impact Assessments, User Requirements, Design Documents, Risk Traceability Matrix, Criticality Assessments, Risk Assessments, Part 11 Assessments, etc.
Review and Approve Validation plans, protocols and reports.
Assess Change Controls for Validation Impact.
Collaborates with stakeholders, engineers, SMEs, and cross functional team members in equipment qualification efforts at Cambridge and PVD facilities.
Participates in continuous improvement and validation maintenance efforts.


Experience in pharmaceutical or biopharmaceutical/biotechnology cGxP environment. Combination of equipment qualification, process validation, computer systems, cleaning, and sterilization is acceptable.
QA pharmaceutical experience is also preferred.
Quality experience with in-depth knowledge of Validation approach, cGxP standards and Risk based validation.
Working knowledge of pharmaceutical and medical device facilities, equipment lyophilization technology and clean room facilities, clean utilities and aseptic fill finish.
Must have direct experience in the commissioning, qualification and validation of facilities, utilities, production, laboratory and support equipment.
Experience working in cell and gene therapy products is a plus.
Knowledge of Industry guidelines (ISPE, PDA) US and international regulations (FDA, cGMP, ICH, ISO, EMA) for validation of GMP facilities.
Must have strong verbal, written and interpersonal communication skills, especially needed to work in a cross-functional


Bachelor's degree in Engineering or related scientific discipline with 5 - 10 years of Pharmaceutical/Biotechnology/Device industry experience or combination of work experience in Validation, QA, MFG, or Engineering.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic.Category: Quality Control, Keywords: Quality Control / Quality Assurance Engineer

Keywords: Yoh, A Day & Zimmermann Company, Boston , Validation Engineer, Engineering , Boston, Massachusetts

Click here to apply!

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

I'm looking for
in category

Other Engineering Jobs

Irrigation Technician
Description: IRRIGATION TECHNICIAN JOB DESCRIPTION Due to our continued growth, Romeiro's Landscaping is hiring an Irrigation Technician to join our team. Candidate must be dependable, self-motivated, accuracy oriented (more...)
Company: Romeiro's Landscape Management
Location: Stoughton
Posted on: 04/14/2021

AWS Cloud Data Engineer- Remote
Description: AWS Cloud Data Engineer General Summary: The AWS Cloud Data Engineer will assist in creating an integrated data pipeline, API, and microservices ecosystem using serverless architectures, languages like (more...)
Company: Yoh, A Day & Zimmermann Company
Location: Charlestown
Posted on: 04/14/2021

Senior .Net Core engineer
Description: A Boston based IOT company that specializes with transportation is seeking a Principal level .NET CORE engineer. Their major clients are in the food medical supplier industry that will be shipping vaccines. (more...)
Company: Management Decisions, Inc.
Location: Boston
Posted on: 04/14/2021

Design Quality Engineer - Med Device CMO - Mansfield, MA
Description: MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an (more...)
Company: Michael Page
Location: Mansfield
Posted on: 04/14/2021

Senior Data Engineer
Description: We are DraftKings. We're inspired by our shared passion for developing creative solutions to complex challenges and empowering the people around us to do their best work. We are industry leaders in the (more...)
Company: DraftKings
Location: Boston
Posted on: 04/14/2021

Hiring Service Technicians - Great Benefits
Description: Reporting directly to the CSC or Delivery Manager, the Service Technician is responsible for the safe and timely tank setup and/or delivery of the product to our customers. The Propane Specialist will (more...)
Company: Superior Plus Energy
Location: Medway
Posted on: 04/14/2021

Data Engineer
Description: 314 Main Street 21020 , United States of America, Cambridge, MassachusettsData Engineer Do you love building and pioneering in the technology space Do you enjoy solving complex business problems in (more...)
Company: Capital One
Location: Marshfield
Posted on: 04/14/2021

Application Security Engineer, Enterprise Engineering
Description: Intro: Facebook's mission is to give people the power to build community and bring the world closer together. Through our family of apps and services, we're building a different kind of company that (more...)
Company: Facebook
Location: Boston
Posted on: 04/14/2021

Field Service Engineer (Medical Imaging)
Description: This position requires current or recent service experience servicing Medical Imaging Devices FDA regulated ......... br Manufacturer of Medical Imaging Instrumentation is in need of a Field Service (more...)
Company: Job Juncture
Location: Boston
Posted on: 04/14/2021

Senior Data Visualization Engineer (Remote)
Description: Description Humana is looking for a self-motivated individual for our Sr. Data Visualization Engineer role. We need someone that has a passion for analyzing data, and creating Visualizations that (more...)
Company: Humana
Location: Boston
Posted on: 04/14/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds