9049 Validation Engineer III
Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures.
Coordinate with laboratory personnel to define qualification requirements.
Author, review and execute equipment qualification protocols including computer system validation and data integrity testing.
Coordinate equipment qualification activities with vendors and other support groups.
Coordinate equipment maintenance activities with vendors and other support groups, as required.
Identify business, quality, and compliance gaps and propose and implement potential improvements to systems and procedures.
Collaborate and author department policies and procedures.
Sign documents for activities as authorized and described by policies, procedures and job descriptions.
Provide input to technical / investigation reports.
Participate in and support internal and external audits and regulatory inspections.
Identify, troubleshoot, and propose resolution to technical problems.
Identify gaps in and potential improvements to systems and procedures.
Receive and provide training.
Provide input to and participate in assay transfer/validation associated with equipment qualification/lifecycle.
Coordinate with customers to support multi-site operational activities.
Present equipment lifecycle and associated procedures/material during internal and external audits and regulatory inspections.
Works to meet schedules and set timelines.
Perform other duties as requested by managers to support Quality activities.
B.S./B.A degree and three years’ experience or Master’s degree plus one year experience or an equivalent combination of education and experience.
Degrees are preferably in relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.
Experience (may vary depending on site size/scope):
Experience with analytical instrument qualification requirements (e.g., USP 1058, 21 CFR Part 820 etc.) and/or computer system validation (e.g., 21 CFR 11, Annex 11 etc.) is desired.
Strong verbal and written communication skills, ability to organize and present information both formally and informally.
Experience in the application of risk management principles.
Proven ability to make sound decisions about scheduling, allocation of resources, and managing priorities.
Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
Routinely exercises sound judgement, reasoning, and problem solving.
Capable of working under moderate supervision and determining own short term priorities.
Valgenesis knowledge a plus.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.