Manufacturing Process Engineer II

Thermo Fisher Scientific•Logan, UT

28d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll 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. Location/Division Specific Information: This role is in the Single Use Division and will be performed at our Logan, Utah location. How You Will Make an Impact: Provides technical support and expertise to sterile pharmaceutical production and, modifications to existing processes and auxiliary support systems. Leads process 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.

Requirements

Minimum Required Education: Bachelor's of Science (preferably in Mechanical, Electrical or Industrial Engineering)
Required: 2 years of process engineering experience.
Outstanding attention to detail and organizational skills to handle time and prioritize tasks.
Strong verbal and written communication skills, and people skills to establish and maintain effective working relationships.
CAD Software Experience in Solidworks and PDM
Strong Excel and Minitab skills

Nice To Haves

Experience with Data Integrity principles for automation systems and audit trail data a plus.

Responsibilities

Encouraging a collaborative team spirit, encouraging a productive and supportive work atmosphere, implementing critical initiatives, and improving the team's skills to boost Overall Equipment Efficiency (OEE) and achieve the business unit's goals.
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).
Documents conditions, actions, and results of work performed following company policies and procedures in logbooks and shift reports.
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.