- Provide technical expertise and support with meeting business unit objectives and increasing production's Overall Equipment Effectiveness (OEE). Maintains system design and associated documentation.
- Diagnoses and resolves difficult process and equipment interactions to maintain system readiness. Frequently, this effort requires collaboration with other teams. Communicates resolution summary to Area Leadership.
- Develops process flow diagrams, problem solving guides, authors Standard Operations Procedures (SOP) and Job Aids to increase process efficiencies and repeatability.
- Creates and leads all aspects of alignment to User Requirement Specifications (URS), Functional Specifications, Design Specifications, and related user documentation to achieve and define process functionality and compliance.
- Establishes technical fit into existing facilities and equipment layouts, identifies process requirements, recognizes efficiency and safety gaps and drives technical solutions.
- Provides supporting data on process systems and equipment to production and quality investigations along with proposing solutions and improvement opportunities.
- Collaborates with Validation, Engineering and Customer teams to ensure process consistency during routine operations and modifications to processes maintain GMP standards (FAT, SAT, IQ/OQ/PQ).
- Develops and Trains resources on technical processes using flow diagrams, job aids and work instructions.
- First Line of Defense for Process Troubleshooting and performs daily floor interactions with Operations, Maintenance, Quality and Safety.
- Owns results by taking actions to correct deficiencies and reports variances and exceptions in processes.
- Drives Continuous Improvements using metrics, TPM, 5S, and the PPI process.
- BS Degree, preferably in Mechanical, Electrical or Industrial Engineering, with three (3) years of process experience.
- 3+ years of Process Improvement experience using Six Sigma, Lean, 5S, Trend Analysis methodologies preferred.
- Successful history in a regulated manufacturing environment in the Biotechnology, Pharmaceutical, and Medical Device industry a plus.
- Experience with Data Integrity principles for automation systems and audit trail data a plus.
- Outstanding attention to detail and interpersonal skills to manage time and prioritize tasks.
- Strong verbal and written communication skills, and people skills to establish and maintain effective working relationships.
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Production Engineer III - Greenville, United States - Thermo Fisher Scientific
Description
Job Description
Location: Greenville, NC
Company Information
As part of the Thermo Fisher Scientific team, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Business Information
The Greenville, North Carolina, USA site is a large, multipurpose pharmaceutical development, manufacturing, and packaging campus. The operation provides both development and commercial services for sterile injectables forms.
Position Summary
Provides technician support and expertise to sterile pharmaceutical production and customer technical transfers, modifications to existing processes and auxiliary support systems. Leads processes improvements to increase safety, reduce costs, improve quality, and improve Overall Equipment Effectiveness (OEE). Emphasizes minimizing production equipment downtime to increase equipment availability and efficiency along with regulatory compliance for process and support systems. Works closely with Production, Maintenance, Validation and Quality to maintain cGMP compliance, injury-free workplace, and on-time product delivery.
Key Responsibilities:
Qualifications:
As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation, and support patients in need #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
