Global medical device supplies manufacturing facility located in Lewisberry, Pennsylvania seeks Sr. Process Engineer to play a key role in leading and optimizing dialysate manufacturing processes—both liquid and dry powder—within a clean, controlled production environment. This position is responsible for driving operational efficiency, ensuring regulatory and cGMP compliance, and supporting the integrity of our clean, non-classified manufacturing spaces. The Sr. Process Engineer will collaborate cross-functionally to implement process improvements, resolve technical challenges, and uphold the highest standards of product quality and safety.
Job title: Sr. Process Engineer
Work Location: Lewisberry, PA
Division/Department: Manufacturing Operations
Reports to: Plant Manager or Director of Manufacturing
Exempt position
$ 100K-110K plus full healthy benefits
Essential Duties and 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.
Education, Certifications and/or Work Experience Requirements:
• Bachelor’s or master’s degree in chemical engineering, Mechanical Engineering, Microbiology, or a related scientific field
• Minimum 5 years of process engineering experience in pharmaceutical, biotech, or medical device manufacturing
• Demonstrated ability to lead and support operations in controlled cleanroom production environments
• Previous exposure to dialysate or parenteral fluid manufacturing
• Proficiency in Lean Six Sigma tools and methodologies (certification preferred)
Skills/Knowledge Requirements:
• Regulatory Knowledge: Strong understanding of FDA regulations, current Good Manufacturing Practices (cGMP), and validation principles.
• Aseptic Practices: Proficient in aseptic techniques, gowning procedures, and contamination control within cleanroom environments.
• Technical Expertise: Hands-on experience with bottling, filling, powder blending, and liquid handling systems.
• Process Improvement: Skilled in process mapping, automation integration, and statistical process control (SPC).
• Risk Management: Experience conducting risk-based assessments such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP).
• Continuous Improvement: Working knowledge of Lean Six Sigma tools and methodologies (certification preferred).
• Industry Knowledge: Familiarity with dialysate or parenteral fluid manufacturing processes.
• Communication Skills: Excellent verbal and written communication skills, with the ability to effectively interact across all levels of the organization.
• Confidentiality: Demonstrated ability to handle sensitive information with professionalism and discretion.
Physical Requirements:
Ability to consistently perform the essential job functions safely and successfully with the ADA, FMLA and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.
Manufacturing:
• Primary work is performed within clean, non-classified production areas requiring adherence to aseptic gowning, hygiene protocols, and safety standards.
• Occasional entry into maintenance and material storage areas with appropriate personal protective equipment (PPE) required.
• Moderate noise levels typical of a manufacturing environment, with exposure to standard production equipment and utility systems.
• Must be able to stand, walk, bend, and move freely for extended periods during process observation or troubleshooting activities.
• Ability to lift and carry materials or equipment weighing up to 25 pounds.
• Manual dexterity and hand-eye coordination required to operate tools, instrumentation, and control panels safely and accurately.
• Must be able to communicate effectively in person, via telephone, and in team settings.
All Staff:
• Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state, and local standards.
Work Model:
Full In-office: This role can only be performed at facilities and are ineligible for remote work.
This position is responsible for operational duties and providing critical infrastructure or services that require physical presence at the facilities.
WORK AUTHORIZATION:
Must be able to provide proof of eligibility to work in the United States at the time of hire and pass a successful background check.
To apply, please email your resume to xjiang@pasona.com
...Your Contribution As a Manager of Logistics reporting to the Plant Manager- Murfreesboro, you will be a key member of the Plant Leadership Team, serving as a true business partner to the Plant Manager. The overall objective is to develop short-term and long-term...
...leader in blood health dedicated to improving patient outcomes through precision medicine and transfusion science. As a Medical Laboratory Scientist, youll perform critical immunohematology testing and ensure the safe and accurate provision of blood products for transfusion...
...could have on the food service industry. There's a seat at our table for you... 2nd Shift Warehouse Package Handler Distribution Center Address: 225 Solar Dr., Imperial, PA Pay: Starting at $20.55/hour ~ Plus, earn two pay raises in your first year...
...A remote survey panel organization is seeking a Data Entry Clerk for an entry-level position. This role allows you to work from home with maximum flexibility and earn extra income. Ideal candidates are self-motivated individuals who enjoy data entry tasks and can follow...
...Job Description Job Description We are lookingto hire an Office Manager to join our team! You will be responsible for overseeing the administrative activities of the organization. Responsibilities: Manage records and information Plan and maintain work facilities...