Sr Automation Validation Engineer

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist working from drug discovery to product development and commercialization. In North America we are headquartered in Princeton NJ with offices in California North Carolina and Mississauga Ontario.

The Sr Automation and Computer System Validation Lead will lead the Commissioning Qualification and Verification of automated and computer systems in support of the NC Manufacturing Facility. Post project implementation the Automation Validation/CSV Lead will be responsible for leading validation activities associated with changes to the validated systems and for routine operations activities applicable to the system validation.

As an individual contributor you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment always acting in line with the organizations values. By using strong interpersonal skills you will work effectively with diverse viewpoints manage relationships thoughtfully and make decisions that meet both individual and team needs. You will be accountable for delivering results adapting to challenges and helping achieve business goals. Additionally you will take ownership of your tasks act with initiative and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

Reporting Relationship: Engineering AD Site CQV Lead

Essential Functions:

Technical Skills Knowledge and Experience
Develop the establishment of the CSV and automation validation program for the Sanford site.
Lead the validation of the selected Automation in the implementation of site automated systems to include a Process Control System Data Historian Environmental Monitoring System and Manufacturing Execution System.
Drive execution of computer system validation and automation system validation with the other functional leads of the capital project delivering an OQ complete status of the facility and associated systems by Q1 2027.
Once the site becomes operational lead ongoing maintenance and continuous improvement of all qualified equipment and computerized systems ensuring continued compliance with cGMP standards regulatory requirements and company procedures.
Lead future capital projects expansions or technological implementations ensuring alignment with site and global automation validation requirements and industry best practices to maintain a state-of-the-art compliant facility.

Subordinates: Individual contributor with the opportunity to potentially lead or coordinate task teams.

Job Requirements:

Education
Bachelors degree in a technical field required. Formal GMP and Safety training is essential.

Experience
At least 7 years of experience in Automation Validation or Automation for BioPharma Manufacturing or Capital Projects with a thorough understanding of CSV. Experience with validation of automated systems in a biopharmaceutical manufacturing facility is essential. Leadership experience in Automation or Validation is preferred. Experience with Tech Transfer is a plus. Background in cGMP regulations GAMP EHS.
Experience with capital project validation and/or starting up and operating a biopharma manufacturing facility is a plus.

Technical Skills
Proficient in MS Office Suite.

Non-Technical Skills
Results-oriented and able to navigate ambiguity you set clear outcomes track progress follow through on commitments and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly take accountability and manage tasks efficiently. Adapt to change with clarity patience and understanding guiding teams through evolving challenges. Exhibit strong organizational skills attention to detail and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others perspectives fostering productive engaging interactions and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect integrity and humility prioritizing collective success over individual gain. Resourceful and proactive challenge the status quo drive innovation and develop creative solutions. Apply an enterprise-wide holistic mindset working beyond siloed thinking to deliver cohesive integrated solutions.

Physical Demands: Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford NC.

Work is 100% on-site. This is not a hybrid or remote role.

Working Conditions: Requires up to 10% domestic and limited international travel.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America Inc. to provide equal employment opportunity to all qualified persons without regard to race religion creed color pregnancy sex age national origin disability genetic trait or predisposition veteran status marital status sexual orientation or affection preference or citizenship status or any other category protected by law.

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Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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