IT Specialist - QC LIMS

Kyowa Kirin is a fastgrowing global specialty pharmaceutical company that applies stateoftheart biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japanbased company our goal is to make people smile by delivering breakthroughs 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 Massachusetts and Ontario.

As a Business Technical Specialist you will lead the North America & North Carolina manufacturing site ICT team in configuration implementation deployment and operational support of manufacturing sites QC IT applications (i.e. LIMS ELN & Other Lab Instrument Software and System / Instrument Integrations). Your responsibilities will include supporting SDLC/ GxP validation activities related to implementation and change controls of QC IT software systems / integrations. Provide functional / technical expertise on system features system functionality access/security controls master data and understanding of the business processes. This role will act as a System Administrator as needed (set up new users and manage security roles) coordinate the needs of QC functional areas and lead LIMS configurations for key business processes in LIMS system related to compliance processes instrument calibration quality operations environment monitoring CoA stability testing vendor compliance manage inventory design of queries and report develop product sampling/test plan.

This role reports into the Director ICT Site Lead

Expertise in LIMS application processes specifically LabVantage
Proficiency in LIMS interfacing navigation and customization to streamline workflows and enhance user experience
Experience in leading projects to conclusion making recommendations for improved outcomes.
Strong understanding and application of ITIL processes and best practices with the ability to independently drive continuous improvement initiatives
Experience with ITSM tools and frameworks leveraging them to optimize service delivery and align IT support with business needs
Demonstrated independence in diagnosing and resolving complex technical issues applying sound judgment and critical thinking to identify root causes and implement effective solutions.
Indepth knowledge of troubleshooting methodologies and the ability to proactively address and mitigate recurring technical challenges
Extensive experience with system administration tasks including advanced configuration performance tuning and optimization to support businesscritical applications
Strong understanding of security best practices risk management and compliance standards ensuring robust protection of business assets and data
Excellent communication and interpersonal skills with a focus on highlevel business partnership and aligning IT support with organizational goals
Ability to manage complex customer inquiries and provide tailored highquality solutions that enhance employee experience and business performance
Advanced capability in creating and maintaining detailed technical documentation ensuring knowledge sharing and alignment across teams
Experience in generating analyzing and presenting actionable technical reports to senior leadership contributing to strategic decisionmaking
High level of customer service focus consistently fostering positive employee and business partner relationships and ensuring a seamless IT experience for all end users

Education
Associates or Bachelors degree in Information Technology Computer Science or a related field.

Experience
At least 3 years of handson IT support experience including troubleshooting complex issues system management and working directly with endusers and business partners; Experience in IT Project Management; Proven ability to thrive in ambiguous fastpaced environments; possess a strategic mindset and Experience with GMP GDP and biopharma manufacturing facilities is a plus.

Technical Skills
Proficient in MS Office Suite.

NonTechnical Skills
Demonstrated ability to organize prioritize meet deadlines make decisions and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic fastpaced high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.
Normal office environment with prolonged sitting and extensive computer work.

Work is 100 onsite. This is not a hybrid or remote role.

Requires up to 10 domestic and 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.

When you apply to a job on this site the personal data contained in your application will be collected and stored by Kyowa Kirin Inc. (Controller) which is located at 510 Carnegie Center Dr. Princeton NJ 08540 USA and can be contacted by emailing Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers recruitment related activities which include setting up and conducting interviews and tests for applicants evaluating and assessing the results thereto and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 61(f) of General Data Protection Regulation (EU) 2016/679 (GDPR) as necessary for the purposes of the legitimate interests pursued by the Controller which are the solicitation evaluation and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software Inc. a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controllers behalf. Accordingly if you are located outside of the United States your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR if you are located in the European Union you have the right to request access to your personal data to request that your personal data be rectified or erased and to request that processing of your personal data be restricted. You also have the right to data portability and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data you may contact us by email at .

Recruitment & Staffing Agencies

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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