What are the responsibilities and job description for the IT Validation Specialist position at AGC Biologics, Inc.?
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.
Are you a curious, detail oriented and committed IT validation specialist?
Do you thrive on sharing knowledge and driving validation activities? Do you have experience within validation and testing?
If yes, then come join our innovative and adventurous journey.
We are looking for a talented IT Validation Specialist to ensure that our IT systems and software meet regulatory compliance and quality standards. As the IT Validation specialist for Applications and Infrastructure, you will be responsible for overseeing projects, as a crucial stakeholder to ensure adherence to GAMP and FDA 21 CFR11 requirements. You will work closely with cross-functional teams to ensure that all systems are compliant with regulatory requirements and industry standards.
You will be a part of a growing and multicultural Global IT Organization, with colleagues in Copenhagen, Milan, Heidelberg, Seattle, Longmont and Boulder.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
Provide expertise in software SDLC (Software Development Life Cycle) and validation with regulatory compliance guidance.
Ability to explain and guide the organization regarding validation requirements.
Knowledge and experience in driving projects that use V-Model and GxP System validation
Review and approve validation documentation, including Validation Master Plans and revalidation procedures.
Coordinate business activities and assign tasks to support the execution of software changes.
Evaluate proposed changes to validated systems and recommend the level of validation activities required.
Partner with Quality, Engineering, and IT teams to define validation processes and ensure compliance with regulations such as GMPs, FDA 21CFR820, FDA 21CFR11, GAMP
Lead the validation efforts for applications and infrastructure, ensuring that all systems are validated and maintained in a compliant state.
Flexible work hours with ability have late start in the day to support US hours.
QUALIFICATIONS
Required:
A relevant degree in Engineering, Computer Science, or a related field.
Proven experience in IT validation, particularly in applications and infrastructure.
Strong knowledge of quality systems and regulatory requirements across multiple health authorities.
A minimum of 3 years of experience within Computer Systems Validation (CSV) in the Pharmaceutical, Biotech or Medical Device Industries.
Excellent communication and leadership skills, with the ability to work effectively in a team environment.
COMPENSATION:
$74,960 - $103,070
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 2,500 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 www.agcbio.com. 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.
Salary : $74,960 - $103,070
