Validation Specialist

at  Sanofi

Reference No. R2779353
Position Title: Validation Specialist
Department: Process Validation
Location: Toronto, Ontario
Duration: 6 months contract

EDUCATION/CERTIFICATIONS

• A degree in Chemical Engineering, Biology, Biochemistry, or Life Sciences combined with 5 to 7 years of relevant work experience within the biopharmaceutical industry. Related to qualification and validation experience in manufacturing, preferably biological industry or equivalent.

REQUIRED QUALIFICATIONS:

• In-depth knowledge of the principle discipline- validation and biopharmaceutical industry compliance (i.e cGXPs, current industry standards and practices, and process/environmental engineering).
• Working knowledge of Microbiology, Biochemistry, Chemical Engineering, Fermentation, Cell and Viral Culture, and Formulation & Stability.
• In depth knowledge of experimental work and data analysis.

ADDITIONAL PREFERRED QUALIFICATIONS:

• Working knowledge and hands-on experience with computer and statistical skills, scientific writing, supervision/management of teams and people (and their development), effective oral and written communication skills, and innovative thinking.
• Familiarity with strategic planning, balanced judgment and risk analysis.
• Strong communication and influencing skills, problem solving, regulatory and compliance trends, strong leadership and management capability

Management of Validation 40%

• Quality Oversight linked to the review and approve protocols linked to validation for manufacturing operations used in GMP areas including lifecycle management.
• Ensures and verify compliance to Regulatory and Corporate validation standards and policies and participates, leads, and provides quality leadership on validation strategies linked to licensed operations.
• This includes the review and approval validation deliverables (i.e. URS, specification documents, risk assessment, study strategies, protocols, reports, validation plans, SOPs, periodic reviews) in accordance with internal and regulatory policies
• Responsible for working with user/system owner to perform validation(s) as per designated validation protocols and to critically evaluate the results to determine if these adequately meet the acceptance criteria.
• Describe the methods required, provide the acceptance criteria and include a rationale for these choices.
• Update and revision of departmental and where applicable company policy/procedures related to validation as required.
• Moreover, support the investigation and closure of non-conformances resulting from validation/qualification studies linked to routine revalidations and other validation activities.
• Also, approve follow-up on, and close corrective and preventative actions (CAPA) and change controls initiated by the respective areas.
• Provide leadership and guidance to the periodic review program, ensuring objectives and timelines are met.
• Manage the plan and report on the metrics to key stakeholders. Assures validation activities for cleaning and/or process validation meet GxP requirements. Support the QOVS owned process and cleaning programs (ie data entry and data management, deviations, etc) by working closely with stakeholders to ensure timelines are achieved and appropriate root cause and corrective/preventative actions as an outcome.
• As required, represent Quality Operations on project teams and/or sub-teams and/or project working groups to provide direction on test method, periodic review, process validation issues with respect to compliance.