Validation Engineer II, Framingham MA

Job description

Summary:

The Validation Engineer II performs commissioning, qualification, and validation activities in support of a cGMP clinical manufacturing facility, which includes clinical fill finish. This individual assures validation activities are performed in conformance with applicable Standard Operating Procedures (SOPs), Sanofi standards, industry best practices, and regulatory requirements. The individual performs validation program related activities such as: DQ, FAT, SAT, IQ, OQ, PQ, CQ, RQ, etc.

Essential Duties and Responsibilities:

·  Writes and executes commissioning, qualification, & validation protocols for facilities, utilities, equipment, and computerized systems
·  Writes final reports
·  Resolves protocol discrepancies and deviations
·  Reviews vendor generated validation protocol packages
·  Generates deviations, CAPAs, root cause analysis, and assists with deviation investigations
·  Participates in the reviews and approvals of internal and external SOPs as they relate to validation
·  Supports change control assessments and deliverables
·  Develops or revises validation SOPs
·  Develops or revises validation master plans and reports
·  Responsible for the generation of complex protocols using a risk based approach that meets current regulatory requirements and industry practices

Education and/or Experience

·  Bachelor's Degree in engineering, science or a related field preferred
·  Minimum of 5 years of experience working in a cGMP regulated environment
·  Minimum of 5 years of operational validation experience in a GMP manufacturing environment
·  Experience with aseptic fill finish automated process equipment preferred
·  Familiar with data logging systems (such as Kaye/GE Validator, ELAB, or Lives International)
·  Basic knowledge of calibration activities, preventative maintenance, and cGMP quality systems preferred
·  Practical knowledge of cGMP regulations required

Supervisory Responsibilities:

·  None

Qualifications:

·  Trained in cGMP Quality systems such as Change Control, CAPA, and Deviation preferred
·  Previous training on cGMP regulations required
·  Trained on risk based validation approaches that meet current regulatory requirements, and industry practices preferred

Computer Skills:

·  Must be proficient with MS Office Word, Excel, Visio, and Project

Certificates, Licenses, Registrations:

·  None Required

Other Skills and Abilities:

·  Excellent oral and written communication and presentation skills
·  Ability to effectively manage time and prioritize tasks independently
·  Excellent organizational skills
·  Ability to manage both day-to-day operations, as well as, project work in a fast-paced environment
·  Ability to effectively manage several tasks simultaneously
·  Must be self-motivated, able to work independently, and have a proven ability to work in a team environment

Physical Demands:

·  This position may require some travel; less than 10%
·  Ability to lift up to twenty pounds and stand for prolonged periods of time

Work Environment:

Must be able to work in a laboratory and cGMP manufacturing environment while wearing appropriate personal protective equipment.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.