QA Validation Engineer

About the role

Purpose

The Validation Engineer supports the development and maintenance of validation activities for facilities, utilities, equipment, systems, processes, cleaning processes, and laboratory instruments in accordance with company standards, health authority regulations, cGMP, and site procedures.

Under the direction of the Validation Section Manager and guidance from senior validation personnel, this individual executes assigned validation activities, prepares and reviews validation documentation, supports routine requalification activities, and helps maintain the validated state of systems at the plant. This role applies established procedures, escalates issues appropriately, and develops validation knowledge while contributing to the effectiveness of the Quality System.

Responsibilities

Main responsibilities for this role include assigned execution, documentation, and support activities, with guidance from management or senior validation personnel as needed.

• Participate in the implementation and maintenance of validation programs and Quality System requirements to meet applicable regulatory and company standards.
• Follow approved practices and procedures to help ensure compliance with company policies, cGMP, and applicable regulations for assigned validation activities.
• Execute assigned tasks that support the Validation Master Plan and help maintain the validated state of equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, sterilization processes, and laboratory instruments.
• Support investigations of validation discrepancies or failures by gathering information, documenting results accurately, and assisting with corrective and preventive actions under supervision.
• Participate with plant, engineering, quality, laboratory, and external resources on new installations or system changes to help ensure commissioning and qualification documentation supports cGMP expectations.
• Support routine qualifications and requalifications by preparing materials, coordinating assigned activities, executing protocols, and helping ensure completion in a timely manner.
• Draft and revise validation-related documents such as protocols, reports, lifecycle documents, user requirements, system classifications, risk assessments, and procedures for review and approval by senior staff or management.

Qualifications & Requirements

Required and preferred qualifications for this role include education, foundational technical skills, and relevant early-career experience.

• Bachelor's degree, preferably in Biology, Chemistry, Engineering, or a related scientific discipline; equivalent relevant experience may be considered where appropriate.
• 2+ years of overall experience in Manufacturing, Quality, Engineering, Validation, or a related regulated environment preferred.
• Good verbal and written communication skills, with the ability to document work clearly and accurately.
• Good problem-solving and analytical skills, with the ability to escalate issues and seek guidance when needed.
• Good interpersonal and cross-functional communication skills.
• Basic knowledge of quality systems, compliance expectations, cGMP, data integrity, and regulations or standards affecting API, bulk drug, or finished goods manufacturing preferred.
• Familiarity with cGMP systems such as RAM, Maximo, KNEAT, TrackWise, and Veeva Vault is a plus.
• Experience with Temperature mapping devices, such as Kaye, Ellab, and Temptales preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.