Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team youll 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 worlds 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 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.
A Day in the Life:
- Guides peer and junior staff through coaching and mentoring encouraging a collaborative team spirit encouraging a productive and supportive work atmosphere implementing critical initiatives and improving the teams skills to boost Overall Equipment Efficiency (OEE) and achieve the business units 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.
Education:
Bachelors of Science preferably in Mechanical Electrical or Industrial Engineering
Experience:
Required: 5 years of process experience.
Preferred: 5 years of Process Improvement experience using Six Sigma Lean 5S Trend Analysis methodologies preferred.
Knowledge Skills Abilities:
- 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 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
What We Offer:
- Annual performance-based bonus
- Annual merit performance-based increase
Excellent Benefits:
- Benefits & Total Rewards Thermo Fisher Scientific
- Medical Dental & Vision benefits - Effective Day 1!
- Paid Time Off & Designated Paid Holidays
- Retirement Savings Plan
- Tuition Reimbursement
- Employee Referral Bonus
- Career Advancement Opportunities
Apply today!
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.