QA Validation

Lonza•Portsmouth, NH

5d•Onsite

About The Position

We are seeking a detail-oriented QA Validation professional to support and oversee validation activities across equipment, processes, utilities, and systems. This role plays a critical part in ensuring compliance with cGMP standards and regulatory requirements while partnering cross-functionally to drive quality and operational excellence.

Requirements

Bachelor’s degree (BS) in Engineering, Life Sciences, or a related field.
Minimum of 5 years of experience in validation/qualification within a GMP-regulated environment.
Strong knowledge of validation and qualification lifecycle principles, including IQ/OQ/PQ and process validation and CSV experience is a plus.
Experience with risk-based validation and qualification approaches and system classification methodologies.
Familiarity with utilities and facilities qualification (HVAC, cleanrooms, water systems, process gases).
Solid understanding of cGMP principles and regulatory expectations (e.g., FDA, EMA).
Experience working with change control, deviation management, and CAPA processes in a GMP environment.
Proficiency in Microsoft Office and experience with quality systems such as TrackWise, SAP, LIMS, KNEAT, or similar platforms.
Strong analytical and decision-making skills, with the ability to evaluate validation strategies and identify compliance risks.
Excellent communication skills, with the ability to clearly present technical information and collaborate across teams.
Proven ability to work effectively in cross-functional environments as a quality partner.
Self-motivated with strong initiative, capable of managing multiple priorities in a fast-paced environment.

Responsibilities

Lead and support validation lifecycle activities, including equipment qualification (IQ/OQ/PQ) and process validation.
Develop, review, and approve validation protocols and reports to ensure compliance with cGMP and regulatory requirements.
Execute and oversee risk-based validation strategies and system classification methodologies.
Support qualification of utilities and facilities (e.g., HVAC systems, cleanrooms, water systems, and process gases).
Collaborate with cross-functional teams (Engineering, IT, QC, Operations) to ensure validation activities are aligned with project and operational goals.
Review and support change control, deviation investigations, and CAPA activities related to validation.
Identify and assess compliance risks and gaps, ensuring appropriate mitigation strategies are implemented.
Drive continuous improvement initiatives within validation processes and documentation practices.
Ensure all validation documentation is maintained in accordance with regulatory and internal quality standards.