Associate Validation Engineer

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Position Summary
The Associate Validation Engineer will assist in the commissioning, qualification, and validation (CQV) of new and modified equipment, facilities, utilities, products, and processes in support of projects, operations, and quality objectives. Working closely with system owners and related stakeholders (Operations, Engineering, Laboratories, IT, and Quality Assurance).  This role will guide CQV activities to a compliant state throughout their lifecycle. This includes authoring, reviewing, and executing related CQV documentation as well as related documents for the role (e.g., procedures and change control records).
The Virginia site serves as the company’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.  
Essential Duties and Responsibilities:

• Execute validation activity as defined by approved protocols and test plans. Where applicable, this includes operating equipment or executing the process which is being validated.
• Perform relevant testing or evaluation during validation and document the results into validation protocols.
• Create detailed and meticulous records during validation activity meeting GMP standards.
• Investigate and troubleshoot validation problems as they occur.

• Complete validation activity in coordination with other related groups (e.g., manufacturing, engineering, or testing labs).
• Understand and apply the understanding of FDA and Quality System Requirements in carrying out duties.
• Support all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
• Executes validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays.
• Evaluate System Change Controls for Validation Impact.  Support Change Qualification through the creation of relevant Change Actions.
• Support the development of Standard Operating Procedures for new processes and equipment.  

Basic Qualifications and Capabilities:

• A minimum of an associate’s degree in a relevant technical field is required (e.g., engineering, biology, chemistry, etc.). Bachelor’s degree is a plus.
• 2+ year’s progressive experience in a manufacturing, quality, technical, or validation role at a pharmaceutical manufacturing / distribution facility, with at least 2 years of validation activity.
• Experience working in cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
• Ability to lead, take ownership, and follow through on assigned projects.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Exposure to a process improvement environment, including change management and participating in Lean/Six Sigma project teams.
• Ability to work autonomously within established guidelines, procedures, and practices.

Preferred Qualifications:

• Experience with regulatory inspections is preferred.
• Experience in a sterile fill-finish facility.
• Start-up experience preferred.
• Knowledge or experience with technical documentation such as P&ID, wiring diagrams, and schematics preferred.
• Experience with validation tools and processes, including temperature mapping and use of Kaye Validator.

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