Thermo Fisher Scientific · 9 hours ago
Manufacturing Process Engineer II
Thermo Fisher Scientific is a global leader in serving science, and they are seeking a Manufacturing Process Engineer II to provide technical support in sterile pharmaceutical production. The role focuses on process improvements, compliance with safety standards, and collaboration with various teams to ensure efficient operations.
BiotechnologyMedical DeviceCloud ComputingEnterprise SoftwareConsultingHealthcareLife ScienceBioinformaticsCloud Data ServicesHealth CareManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
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
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
Qualification
Required
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Minimum Required Education: Bachelor's of Science (preferably in Mechanical, Electrical or Industrial Engineering)
Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Experience with Data Integrity principles for automation systems and audit trail data
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
Preferred
At least 1 year of process engineering experience
Benefits
Annual performance-based bonus
Annual merit performance-based increase
Medical, Dental, & Vision benefits - Effective Day 1!
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Employee Referral Bonus
Career Advancement Opportunities
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
Funding
Current Stage
Public CompanyTotal Funding
$19.77BKey Investors
National Grid
2026-02-09Post Ipo Debt· $3.8B
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
Recent News
Boston Herald
2026-02-07
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