Senior Process 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 North America we are headquartered in Princeton NJ with offices in California North Carolina and Mississauga Ontario.

Summary of Job

The Senior Process Engineer is responsible for the design commissioning and operation of the KKNA Manufacturing Facility including Tech Transfer Process Definition Troubleshooting and Process Optimization.

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. You will work effectively across diverse teams 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.

Essential Functions :

• Provide hands-on support and guidance for the installation maintenance troubleshooting and repair of assets and systems supporting the manufacturing facility
• Assume system ownership within Upstream Processing Downstream Processing or Solution Preparations maintaining cradle-to-grave accountability from design through operations acceptance
• Draft review and approve documentation including operating procedures maintenance plans engineering drawings and equipment specifications
• Participate in Operational Readiness (OR) planning and execution
• Collaborate with Manufacturing Manufacturing Sciences and Automation to evaluate and support new product introductions
• Support preparation of maintenance calibration and qualification plans
• Manage technical and engineering changes through the change control process
• Support internal and external audits
• Execute all work in alignment with regulatory requirements

Education

• Bachelors degree in Chemical Engineering Mechanical Engineering Biotechnology Engineering or a related field

Experience

• Minimum 5 years experience as a process engineer in Pharma Biopharma and/or Life Science industries in a manufacturing/operations role.
• Knowledge and experience of Single Use Technology (SUT) preferably in monoclonal antibody (mAb) processing. Knowledge and understanding of Good Manufacturing Practices (GMP) and quality compliance issues related to both clinical and commercial manufacturing.
• Experience with starting up and operating a biopharma manufacturing facility is a plus.

Technical Skills

• Proficiency in Microsoft Office Suite
• Strong troubleshooting and process optimization capabilities
• Experience with change control documentation and regulatory compliance

Additional Skills & Competencies

• Strong organizational and time management skills with the ability to meet deadlines
• Excellent written and verbal communication skills
• Strong attention to detail and follow-through
• Ability to work independently and adapt in a dynamic fast-paced environment
• Demonstrated ability to manage ambiguity and shifting priorities
• Commitment to continuous learning and development
• Ability to build relationships and collaborate across a global organization

Work Environment & Requirements

• 100% on-site role in Sanford NC (not remote or hybrid)
• Initial work may be in a construction/startup environment transitioning into a biotech manufacturing site
• Up to 10% domestic and international travel required

Additional Information

This is an individual contributor role with no direct reports. The role may lead or support special projects and cross-functional initiatives as needed

The anticipated salary for this position will be$135000 to $155000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience skill set qualifications education (including applicable licenses and certifications job-based knowledge location and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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. 6(1)(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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