Company: Yoh, A Day & Zimmermann Company
Posted on: April 10, 2021
Temporary Validation Engineer
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
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
Review lifecycle documents such as Impact Assessments, User
Requirements, Design Documents, Risk Traceability Matrix,
Criticality Assessments, Risk Assessments, Part 11 Assessments,
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
Experience in pharmaceutical or biopharmaceutical/biotechnology
cGxP environment. Combination of equipment qualification, process
validation, computer systems, cleaning, and sterilization is
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
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
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
https://www.yoh.com/applicants-with-disabilities 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
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