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.





Responsibilities


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.








Qualifications


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





Education


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