Operational Excellence Site Specialist (GMP) - Long Island, NY

Thermo Fisher Scientific•Bohemia, NY

32d•$66,000 - $110,000•Onsite

About The Position

Join our Pharma Services Group (PSG) team and be part of a leading contract development and manufacturing organization (CDMO) offering end-to-end services for drug development, clinical trial logistics, and commercial manufacturing. Biotech and biopharma companies rely on us for speed, flexibility, and quality across every phase of development. Our Clinical Trials Division (CTD) supports pharmaceutical, biotechnology, and contract research organizations (CROs) in conducting efficient and successful clinical trials. Our teams provide comprehensive clinical supply chain services, including packaging, labeling, and distribution. You will join our Bohemia site — a Clinical Label Services (CLS) production facility specializing in clinical label design, print production, inspection, reconciliation, and global distribution for the pharmaceutical and biotechnology industry. DESCRIPTION: We are seeking a motivated and execution-focused Operational Excellence Specialist (PPI Specialist) to support operational readiness, process robustness, and compliance performance within our Bohemia CLS production site. As an Operational Excellence professional in a GMP production environment, you will play a hands-on role in strengthening process stability, improving right-first-time execution, reducing operational variation, and driving disciplined execution across the site. This position supports deployment of Thermo Fisher’s Practical Process Improvement (PPI) Business System and actively leverages structured mechanisms — including Change Controls and CAPAs — to implement sustainable process improvements, enhance compliance performance, and reduce reactive workload.

Requirements

Bachelor’s degree in Engineering, Business Administration, Life Sciences, or related field; Master’s degree preferred
Minimum of 3 years of experience in operational excellence with bachelor's degree, process improvement, or operations within a GMP-regulated pharmaceutical, biotech, or clinical supply production environment. Minimum of 1 year of experience with master's degree.
Demonstrated experience driving operational improvements that strengthen compliance and reduce recurring events
Demonstrated knowledge and practical application of Operational Excellence methodologies, such as Value Stream Mapping, process mapping, Tiered Daily Accountability, A3 problem solving, and Plan-Do-Check-Act (PDCA)
Lean Six Sigma Green Belt preferred
Strong knowledge of GMP-regulated production environments
Experience utilizing Change Controls and CAPAs as mechanisms to drive structured, sustainable process improvement
Proficiency in Microsoft Power Platform (Power Automate, Power Apps, Power BI)
Experience implementing and sustaining 5S and visual management systems
Strong analytical, structured problem-solving, and execution-focused skill set
Ability to influence cross-functional teams without direct authority

Nice To Haves

Experience in clinical supply chain or clinical label production environments preferred

Responsibilities

Drive operational excellence initiatives focused on improving production stability, flow, execution discipline, and sustained compliance within the CLS production environment
Strengthen operational readiness by improving documentation practices, process adherence, and standardized execution across production workflows
Actively support and drive compliance by reinforcing process control, reducing variability, and ensuring operational alignment with GMP requirements
Utilize Change Controls and CAPAs as structured improvement tools to implement, formalize, and sustain operational process enhancements
Identify and address systemic operational gaps that contribute to rework, recurring events, execution instability, or compliance risk
Strengthen upstream process controls to reduce downstream disruptions in label design, print production, inspection, and reconciliation
Reinforce disciplined execution of operational changes to minimize unintended impact and ensure controlled implementation
Apply structured problem-solving methodologies (Lean, Six Sigma, root cause analysis) to eliminate inefficiencies and strengthen process robustness
Implement and sustain 5S and visual management systems within production areas to improve transparency and accountability
Utilize Microsoft Power Automate, Power Apps, and Power BI to enhance process visibility, automate tracking mechanisms, and improve operational data integrity
Develop and maintain KPI dashboards related to right-first-time performance, rework trends, cycle time, throughput, and operational event patterns
Facilitate team-level improvement workshops and support Kaizen events aligned to operational and compliance priorities
Develop process maps, standard work documentation, and job aids that reflect disciplined execution practices
Collaborate throughout the organization — including Production, Planning, Engineering, Client Services, Quality, and Leadership — to strengthen cross-functional communication and execution consistency
Support sustainment of implemented improvements through follow-up, metric monitoring, and accountability reinforcement

Benefits

Excellent Benefits Package
Review our company’s Total Rewards
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 5%
Tuition Reimbursement – eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
The salary range estimated for this position based in New York is $66,000.00–$110,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards