Kyowa Kirin North America
Senior Manufacturing Operator
Sanford, NC · Senior
Sponsorship not specifiedDetected 34 days ago
AgileERPGMPCommunicationCollaborationProblem SolvingAdaptabilityOrganizational SkillsMicrosoft OfficeLean Manufacturing
About the role
- 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.
- Summary of Job As a Senior Manufacturing Operator supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will be tasked to start up and execute core manufacturing operations.
- You will be a role model for Safety and Compliance.
Requirements
- Experience with relevant Upstream operations, including:
- Experience with relevant Downstream operations, including:
- Direct Upstream and Downstream GMP manufacturing experience required.
Nice to have
- Adhere to operational procedures and master records and follow both written and verbal instructions from supervisors.
- Maintain accurate records, including batch records, log sheets, and other required documentation.
- Escalate any and all non-compliance events (perceived or actual) in a timely manner.
- Ensure compliant and efficient operations throughout commissioning and manufacturing operations by collaborating with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams.
- Utilize enterprise systems supporting manufacturing operations, including but not limited to ERP, LIMS, MES, PCS, QMS, and BMS.
- Bachelor's degree in a technical field (Chemical Engineering, Chemistry, Biology, or related discipline) preferred.
- Bachelor's degree plus a minimum of 4 years of relevant biopharmaceutical manufacturing experience
- Associate's degree plus a minimum of 6 years of relevant biopharmaceutical manufacturing experience
Skills
- Knowledge of Agile and Lean Manufacturing principles and Standard Work.
- Proficiency with Microsoft Office applications.
- Strong problem-solving and critical-thinking skills.
- Experience authoring or editing SOPs preferred.
- Experience with electronic records and PCS software such as DeltaV, Unicorn, Ignition, or similar systems preferred.
- Ability to read and interpret technical documents.
- Ability to troubleshoot and operate production equipment.
- Ability to perform basic math and statistics.
- Strong written and verbal English communication skills
- Non-Technical Skills
- Strong accountability and follow-through on commitments.
- Adaptability and resilience in a rapidly changing environment.
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