Senior Process Engineer

NIPRO Corporation - Global; Lewisberry (PA); On-site; USD 80,000 - 115,000; Full time

Job summary

A leading company in medical equipment manufacturing seeks a Senior Process Engineer to optimize dialysate manufacturing processes. The role involves ensuring compliance with FDA regulations and good manufacturing practices while leading process improvements in a clean environment. Candidates should have a strong background in chemical or mechanical engineering and extensive experience in pharmaceutical manufacturing.

Benefits

Medical Insurance

Dental Insurance

Life Insurance

401K plan with company match

Employee Referral Bonus

Career development opportunities

Qualifications

• Minimum 7 years of process engineering experience in pharmaceutical or biotech manufacturing.
• Strong knowledge of FDA regulations and cGMP.

Responsibilities

• Design and implement manufacturing processes to enhance yield and reduce variability.
• Plan and execute validation protocols for equipment and processes.

Skills

Lean Six Sigma

Communication

Problem-Solving

Education

Bachelor’s or Master’s degree in Chemical Engineering

Microbiology

Tools

Statistical Process Control

Automation Integration

Job description

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We are seeking a skilled and experienced Senior Process Engineer to lead and optimize our dialysate manufacturing processes—both liquid and dry powder—within a clean, controlled manufacturing environment. This individual will play a critical role in ensuring operational efficiency, regulatory compliance, and adherence to good manufacturing practices (cGMP), while supporting the integrity of our clean, non-classified production spaces.

Responsibilities

Process Optimization

• Design, implement, and continuously improve manufacturing processes to enhance yield, reduce variability, and minimize downtime.
• Apply Lean Six Sigma principles to support root cause analysis, defect reduction, and operational excellence.
• Lead structured problem-solving events with cross-functional teams.

Clean Manufacturing Operations

• Maintain and reinforce disciplined behaviors within clean, non-classified production environments.
• Oversee production line activities to ensure compliance with gowning, hygiene, and contamination control protocols.
• Champion cleanroom-like standards in gowning, personnel practices, and process flow without the constraints of ISO classification.

Validation and Regulatory Compliance

• Plan and execute validation protocols (IQ/OQ/PQ) for new and existing equipment and processes.
• Ensure production activities meet all FDA, cGMP, and internal quality standards.
• Manage and maintain documentation to support regulatory audits and inspections.

Equipment and Automation

• Optimize equipment performance including bottling lines, conveyor systems, and powder handling equipment.
• Work closely with maintenance and automation teams to troubleshoot issues, introduce upgrades, and extend equipment lifecycle.
• Identify automation opportunities and lead capital projects that drive manufacturing scale-up and reliability.

Technical Leadership and Collaboration

• Serve as a process subject matter expert supporting daily production, change controls, and continuous improvement initiatives.
• Partner with Quality, Validation, Maintenance, and Supply Chain teams to ensure process readiness and robustness.
• Mentor junior engineers and provide technical leadership across cross-functional project teams.

Qualifications and Experience

• Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Microbiology, or related scientific field.
• Minimum 7 years of process engineering experience in pharmaceutical, biotech, or medical device manufacturing.
• Demonstrated ability to lead and support operations in controlled clean production environments.
• Experience with aseptic practices, gowning procedures, and contamination control.
• Strong knowledge of FDA regulations, cGMP, and validation principles.
• Proficiency in Lean Six Sigma tools and methodologies (certification preferred).
• Hands-on experience with bottling, filling, powder blending, and liquid handling systems.
• Excellent written and verbal communication skills.
• Previous exposure to dialysate or parenteral fluid manufacturing.
• Process mapping, automation integration, or statistical process control experience.
• Experience in risk-based assessments (FMEA, HACCP) and data-driven process improvement.
• Primary work occurs within clean, non-classified production spaces requiring adherence to gowning and hygiene standards.
• Moderate noise levels and exposure to standard production equipment.
• Occasionally required to enter maintenance or material storage areas with appropriate PPE.

Physical Requirements

• Able to stand and walk for prolonged periods.
• Capable of lifting up to 25 pounds.
• Manual dexterity to work with tools, instrumentation, or control panels.

We offer a competitive salary plus benefits that include:

• Medical, Dental, Life Insurance and Employee Assistance Program
• 401K plan with company match
• Employee Referral Bonus
• Open and team-oriented work atmosphere
• Career development and advancement opportunities

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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