Shire is a leading global biologics manufacturer opening state of the art facility outside of Atlanta, GA. This position will play a key role in start-up operational readiness and supporting maintenance department in areas like OOTs remediation; documents authoring, deviations investigation and CAPA determination and change controls implementation
Drive maintenance compliance deliverables to ensure successful commercial operations, including:
• Lead CAPA investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by:
• Lead problem solving and root-cause analysis sessions
• Interact with Manufacturing, Quality, Engineering and Tech Service units
• Manage complex investigations using DMAIC tools
• Ensure effective implementation of corrective and preventive actions
• Lead investigations to resolve Out Of Tolerance instrument and equipment calibrations
• Author and revise GMP documents, SOPs and engineering documents (e.g. PNIDs, Job Plans, Calibrations Procedures, ICLs, ICAs, Maintenance Assessments, Equipment Lifecycle, etc.)
• Train staff in general compliance calibration and maintenance procedures
• Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks
• Identify and implement improvement initiatives to improve calibration, equipment reliability, and/or maintenance process robustness. This may require leading and implementing change controls
• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability
• Stay current with biopharmaceutical industry best practices and technologies
• Responsible for organizing data and preparing appropriate documentation, including presentation materials for assigned projects.
• Gather and analyze empirical data, organize, maintain and present metrics and key performance indicators. Requirements:
Education and/or Experience:
- Strong problem solving and analytical skills are required.
- Possess knowledge of core manufacturing principles and support systems
- Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross functional teams and management on recommended course of action, with minimal assistance.
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
Self-driven individual that requires minimal supervision
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).
- Working Flexible or alternate shifts may be required based on business needs.
- Bachelor of Science or Technical degree required
- 0-4 years work experience
Professional (GMP industry) experience ideal but not required Working Environment:
- May occasionally work in a clean-room environment and wear special garments (requires removal of make-up and jewelry)
- May occasionally wear personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas. Company provides PPE
- May be required to work weekends, evenings, and off-hours, extended periods of time