Senior Process Engineer-Upstream

1 week ago


Sanford, North Carolina, United States Kyowa Kirin North America Full time
Job Summary:

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. This role requires collaboration with the team, demonstrating compassion and integrity in all work, and utilizing ability to facilitate alignment among diverse viewpoints to make informed decisions and drive consensus.

Key Responsibilities:
  • Provide hands-on support and guidance of installation, maintenance, troubleshooting, and repair of assets and systems supporting the manufacturing facility.
  • Take system ownership within Upstream Processing, Downstream Processing, or Solution Preparations and maintain a 'cradle-to-grave' accountability for the systems assigned, from design through operations acceptance.
  • Create, review, and approve documentation such as operational procedures, maintenance plans, engineering drawings, and equipment specifications.
  • Participate in the facility's Operational Readiness (OR) planning and execution.
  • Collaborate with manufacturing, manufacturing sciences, and automation to evaluate new product introductions.
  • Assist with preparation of maintenance, calibration, and qualification plans.
  • Manage technical and engineering changes (change control).
  • Support internal and external audits.

Requirements:

Bachelor's degree qualified in Chemical, Mechanical, or biotechnology engineering or related field. 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.

  • Sanford, North Carolina, United States Kyowa Kirin North America Full time

    Kyowa Kirin North America is a leading global specialty pharmaceutical company that leverages cutting-edge biotechnologies to develop innovative medicines in four key areas: bone and mineral, hematology oncology, and more. Our mission is to bring breakthrough treatments to patients in need, from drug discovery to commercialization.The Senior Process Engineer...


  • Sanford, North Carolina, United States Rogers Freels & Associates Inc Full time

    Job SummaryRogers Freels & Associates Inc is seeking a skilled Manufacturing Engineer II to join our team. As a key member of our engineering staff, you will apply Lean Manufacturing methodologies to improve efficiency and reduce costs throughout the manufacturing process.Key ResponsibilitiesProcess Optimization: Establish and implement efficient...


  • Sanford, North Carolina, United States Rogers Freels & Associates Inc Full time

    Job SummaryRFA Engineering is seeking a skilled Manufacturing Engineer II to join our team. As a key member of our engineering staff, you will apply Lean Manufacturing methodologies to improve efficiency and reduce costs throughout the manufacturing process.This is a full-time position with a competitive benefits package, including opportunities for...


  • Sanford, North Carolina, United States Rogers Freels & Associates Inc Full time

    Job SummaryRogers Freels & Associates Inc is seeking a skilled Manufacturing Engineer II to join our team. As a key member of our engineering staff, you will apply Lean Manufacturing methodologies to improve efficiency and reduce costs throughout the manufacturing process.Key ResponsibilitiesProcess Optimization: Establish and implement efficient production...


  • Sanford, North Carolina, United States Coty Full time

    Join Our Team as a Process Engineering Co-op/InternCoty is seeking a talented and motivated Process Engineering Co-op/Intern to join our team. As a Process Engineering Co-op/Intern, you will have the opportunity to work on real-world projects, develop your skills, and contribute to the success of our manufacturing facility.About the RoleThis is a unique...


  • Sanford, North Carolina, United States Astellas Pharma Full time

    Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.Our company is seeking a Senior Onsite Support Engineer to provide comprehensive onsite technology support and services...


  • Sanford, North Carolina, United States Astellas Pharma Full time

    About the RoleAstellas Pharma is seeking a highly skilled and experienced Senior Onsite Support Engineer to join our team. As a key member of our IT department, you will be responsible for providing comprehensive onsite technology support and services to ensure optimal performance of all IT infrastructure and systems at assigned sites.Key...


  • Sanford, North Carolina, United States Net2Source Inc. Full time

    Job Title: Design Manufacturing EngineerNet2Source Inc. is a leading provider of global workforce solutions, headquartered in NJ, USA, with a strong presence in the Asia Pacific Region. We are seeking a highly skilled Design Manufacturing Engineer to join our team.Job Summary:We are looking for a talented engineer to work on designing and developing...

  • Automation Engineer

    3 weeks ago


    Sanford, North Carolina, United States Pfizer Full time

    Job Title: Automation EngineerJoin Pfizer's innovative engineering team as an Automation Engineer and play a critical role in the management of manufacturing information systems to improve manufacturing success rates and ensure zero downtime.Key Responsibilities:Design, develop, deploy, and test automated processes, systems, and equipment.Maintain and...

  • Senior MES Consultant

    3 weeks ago


    Sanford, North Carolina, United States United Software Group Full time

    Job Title: Senior MES ConsultantWe are seeking a highly skilled Senior MES Consultant to join our team at United Software Group. As a key member of our organization, you will be responsible for designing and implementing Manufacturing Execution Systems (MES) for our clients in the pharmaceutical industry.Key Responsibilities:Design and develop business...


  • Sanford, North Carolina, United States Zurn Elkay Water Solutions Full time

    Senior Maintenance TechnicianZurn Elkay Water Solutions Corporation is a values-driven company focused on doing the right things. We're a fast-growing, publicly traded company (NYSE: ZWS), with an enduring reputation for integrity, giving back, and providing an engaging, inclusive environment where careers flourish and grow.Job SummaryThe Sr. Maintenance...


  • Sanford, North Carolina, United States Rogers Freels & Associates Inc Full time

    Job Title: Manufacturing Engineer IIRogers Freels & Associates Inc is seeking a skilled Manufacturing Engineer II to join our team. As a key member of our engineering staff, you will apply Lean Manufacturing methodologies to improve efficiency and reduce costs throughout the manufacturing process.Key Responsibilities:Establish routings, methods, processes,...


  • Sanford, North Carolina, United States Caterpillar, Inc. Full time

    Career Opportunity at Caterpillar, Inc.Career Area: ManufacturingJob Description:We are seeking a skilled Fabrications Manufacturing Engineering Manager to join our team at Caterpillar, Inc. in Sanford, NC. As a key member of our manufacturing team, you will play a critical role in planning and directing the fabrications CI and planning functions to meet...


  • Sanford, North Carolina, United States COTY US LLC Full time

    Join Our Team as a Facilities and Sustainability Co-opCoty US LLC is seeking a highly motivated and detail-oriented individual to join our team as a Facilities and Sustainability Co-op. This is an excellent opportunity to gain hands-on experience in a manufacturing environment and contribute to our company's sustainability goals.Key Responsibilities:Lead...


  • Sanford, North Carolina, United States Pentair Management Company Full time

    Pentair Supply Chain & Operations Leadership Development ProgramUnlock Your Potential with Pentair's Leadership Development ProgramPentair invites ambitious and forward-thinking students to apply to our 12-week summer internship program. As a Supply Chain & Operations Leadership Development Intern, you will embark on a transformative experience where...

  • Electrical Estimator

    4 weeks ago


    Sanford, North Carolina, United States Ace Electric Full time

    Job Title: Junior EstimatorWe are seeking a highly skilled Junior Estimator to join our team at Ace Electric, Inc. As a Junior Estimator, you will play a crucial role in assisting our Senior Estimator in all aspects of electrical estimating, including analyzing blueprints, writing proposals, and preparing cost and expenditure statements.Key...


  • Sanford, North Carolina, United States Astellas Pharma Full time

    About Astellas Gene TherapiesAstellas Gene Therapies is a leading pharmaceutical company dedicated to developing innovative genetic medicines for patients with rare, life-threatening diseases. Our team is passionate about turning science into medical solutions that bring value and hope to patients and their families.The RoleWe are seeking a highly skilled...


  • Sanford, North Carolina, United States Caterpillar Full time

    Job Title: Facility Quality ManagerCaterpillar is seeking a highly skilled Facility Quality Manager to join our team in Sanford, NC. As a key member of our quality management team, you will be responsible for overseeing all quality organizations, including quality production processes, incoming quality audits, calibration processes, quality engineering, root...

  • Electrical Estimator

    4 weeks ago


    Sanford, North Carolina, United States Ace Electric Full time

    Job Title: Junior EstimatorWe are seeking a highly skilled and motivated Junior Estimator to join our team at Ace Electric, Inc. As a Junior Estimator, you will play a crucial role in assisting our Senior Estimator in all aspects of electrical estimating, including analyzing blueprints, writing proposals, and preparing cost and expenditure statements.Key...


  • Sanford, North Carolina, United States Zurn Elkay Full time

    Job SummaryZurn Elkay Water Solutions Corporation is a leading international supplier of plumbing and water delivery solutions, and we're seeking a skilled Sr. Maintenance Tradesperson to join our team.This is a hands-on role that requires a high level of technical expertise and problem-solving skills. As a Sr. Maintenance Tradesperson, you will be...