Validation Engineer III

Bothell, WA - USA

Monthly Salary: $ 94000 - 129250

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job Summary

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.

Job Summary

We are looking for a Validation Engineer III to support qualification and validation of facilities utilities equipment analytical systems and computerized systems used in the manufacture of cGMP protein-based therapeutics including cell and gene therapies. This role plays a key part in ensuring systems remain compliant inspection-ready and aligned with regulatory and quality standards.

The Validation Engineer III partners closely with Engineering Operations Quality and customer project teams to execute validation strategies support continuous improvement and maintain a strong state of compliance across the site.

Location: Bothell WA
Schedule: Onsite Monday - Friday
Compensation: $94000 $129250

Key Responsibilities

Lead and execute equipment facility utility and system validation activities.
Prepare and execute IQ/OQ/PQ protocols for manufacturing equipment analytical instruments facilities and utilities (e.g. HVAC BAS compressed air nitrogen).
Support commissioning and engineering studies related to new and existing systems.
Generate and review qualification reports and validation documentation for internal and regulatory use.
Manage requalification activities in support of change control.
Initiate and support deviations change controls and CAPAs related to validation activities.
Develop and maintain validation traceability matrices and GMP criticality assessments.
Analyze validation data and ensure documentation meets Good Documentation Practices and regulatory requirements.
Partner with Quality Engineering and Operations to define validation strategies and ensure inspection readiness.
Support investigations and risk assessments related to equipment and process validation.
Identify and propose remediation for validation gaps or compliance risks.
Provide validation and quality expertise to internal teams and customer projects.

Qualifications

Bachelors degree with 8 years of relevant validation experience or Masters degree with 6 years of relevant experience.
Experience validating facilities utilities equipment and computerized systems in a cGMP environment.
Strong knowledge of GMP ICH and ISO requirements.
Experience with change control deviations investigations and CAPA processes.
Experience supporting regulatory inspections and audits.
Strong organizational communication and problem-solving skills.
Ability to manage multiple priorities in a fast-paced regulated environment.
Collaborative team-oriented mindset with attention to detail.

Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMP-compliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.

Required Experience:

Job Summary

Location: Bothell WA
Schedule: Onsite Monday - Friday
Compensation: $94000 $129250

Key Responsibilities

Lead and execute equipment facility utility and system validation activities.
Prepare and execute IQ/OQ/PQ protocols for manufacturing equipment analytical instruments facilities and utilities (e.g. HVAC BAS compressed air nitrogen).
Support commissioning and engineering studies related to new and existing systems.
Generate and review qualification reports and validation documentation for internal and regulatory use.
Manage requalification activities in support of change control.
Initiate and support deviations change controls and CAPAs related to validation activities.
Develop and maintain validation traceability matrices and GMP criticality assessments.
Analyze validation data and ensure documentation meets Good Documentation Practices and regulatory requirements.
Partner with Quality Engineering and Operations to define validation strategies and ensure inspection readiness.
Support investigations and risk assessments related to equipment and process validation.
Identify and propose remediation for validation gaps or compliance risks.
Provide validation and quality expertise to internal teams and customer projects.

Qualifications

Bachelors degree with 8 years of relevant validation experience or Masters degree with 6 years of relevant experience.
Experience validating facilities utilities equipment and computerized systems in a cGMP environment.
Strong knowledge of GMP ICH and ISO requirements.
Experience with change control deviations investigations and CAPA processes.
Experience supporting regulatory inspections and audits.
Strong organizational communication and problem-solving skills.
Ability to manage multiple priorities in a fast-paced regulated environment.
Collaborative team-oriented mindset with attention to detail.