Process Engineer

RXinsider LTD.; Kentucky; On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Healthcare

Prescription drug coverage

Flexible spending accounts

Wellness

Disability coverage

401k match

EAP (Employee Assistance Program)

Life insurance

PTO (Paid Time off)

Holidays

Job summary

Centor/Gerresheimer in Ohio is seeking a Process Engineer to own and stabilize manufacturing processes within a production building. You will partner with Production, Quality, Maintenance, and Supply Chain to improve process robustness and reduce variability.

The role focuses on ensuring processes are compliant, capable, and scalable to meet safety, quality, delivery, and cost targets, while leading Lean improvements and validation activities in a regulated environment.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related field).
• 2–4 years of process engineering experience in manufacturing.
• Strong knowledge of SPC, Lean/Six Sigma, RCA, and validation methodologies.
• Experience in regulated manufacturing preferred.

Responsibilities

• Process Ownership & Stability: Own and maintain process parameters for all production lines within the assigned building.
• Define standard operating windows and control limits.
• Monitor and improve process capability (Cp, Cpk).
• Ensure process documentation (work instructions, parameter sheets) is current and accurate.
• Provide on-floor technical support during process deviations.
• Process Optimization & Continuous Improvement: OEE, FA/RFT, Scrap reduction, Cycle time optimization.
• Lead structured problem-solving (DMAIC, 5-Why, Fishbone diagrams).
• Implement Lean manufacturing initiatives.
• Reduce cost of non quality (CNQ).
• Validation & Change Management: Support IQ/OQ/PQ activities.

Skills

SPC

Lean Six Sigma

Root cause analysis

Process validation

Regulated manufacturing

Education

Bachelor’s degree in Engineering

Job description

Company Summary: Centor is a Gerresheimer company. Centor/Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Centor/Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).

Job Title: Process Engineer

Reports To: Operations Manager

Location: Berlin, Ohio

Industry: Packaging Manufacturing

Position Summary

The Process Engineer is responsible for the technical ownership, stability, and continuous improvement of manufacturing processes within an assigned production building or value stream. This role ensures processes are capable, efficient, compliant, and scalable while supporting production performance targets related to safety, quality, delivery, and cost.

The Process Engineer partners closely with Production, Quality, Maintenance, and Supply Chain to optimize process robustness and reduce variability.

Organizational Context

• Embedded within assigned building / Building Unit
• Reports to: Operations Manager
• Matrix collaboration with:
  • Building Operations Manager
  • Quality Engineer
  • Maintenance Manager
  • Production Supervisors

The Process Engineer acts as the technical authority for process performance within the building.

Core Responsibilities

• Process Ownership & Stability
• Own and maintain process parameters for all production lines within the assigned building.
• Define standard operating windows and control limits.
• Monitor and improve process capability (Cp, Cpk).
• Ensure process documentation (work instructions, parameter sheets) is current and accurate.
• Provide on-floor technical support during process deviations.
• Process Optimization & Continuous Improvement
  • OEE (Overall Equipment Effectiveness)
  • First Acceptance (FA) / RFT (right first time)
  • Scrap reduction
  • Cycle time optimization
• Lead structured problem-solving using:
  • DMAIC methodology
  • 5-Why analysis
  • Fishbone diagrams
• Implement Lean manufacturing initiatives.
• Reduce cost of non quality (CNQ).
• Validation & Change Management (Regulated Environment)
  • Support validation activities such as:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Ensure process changes follow formal change control procedures.
• Conduct risk assessments (FMEA) for new or modified processes.
• Support compliance with:
  • International Organization for Standardization standards (ISO 9001 / ISO 13485 as applicable)
  • Good Manufacturing Practices (GMP)
  • U.S. Food and Drug Administration regulations (if applicable)
• Equipment & Technology Support
  • Collaborate with Maintenance on preventive maintenance strategies.
  • Define critical process parameters (CPPs).
  • Support installation and commissioning of new equipment.
  • Lead process trials and line qualifications.
  • Analyze downtime trends and implement corrective measures.
• Data & Statistical Analysis
  • Analyze SPC data and process variation.
  • Perform capability studies.
  • Develop dashboards for process performance monitoring.
  • Utilize statistical tools to identify systemic risks.
• Cross-Shift Process Governance

In multi-shift operations

• Ensure consistent process execution across all shifts.
• Audit parameter adherence.
• Standardize troubleshooting guides.
• Support off-shift escalation when major technical issues arise.

Authority Level

• Adjust process parameters within validated ranges
• Recommend production holds due to technical risk
• Initiate engineering change requests
• Require corrective technical actions for process nonconformance

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, or related field)
• 2–4 years of process engineering experience in manufacturing
• Strong knowledge of:
  • Statistical process control (SPC)
  • Lean / Six Sigma tools
  • Root cause analysis
  • Process validation methodologies
• Experience in regulated manufacturing preferred

Preferred Qualifications

• Lean Six Sigma Green Belt or Black Belt
• Experience in plastics, injection molding, extrusion, or automated packaging systems
• Validation experience in pharmaceutical or medical-related industries
• Project management experience

Key Competencies

• Analytical and data-driven decision making
• Strong floor presence and hands-on problem solving
• Technical documentation discipline
• Cross-functional collaboration
• Risk-based thinking
• Ability to balance production urgency with long-term robustness

Performance Metrics

• OEE improvement
• Scrap and CNQ % reduction
• Process capability (Cpk targets)
• Downtime reduction
• Successful validation completion
• On-time implementation of engineering changes
• First Acceptance (FA) / RFT (right first time)

Salary Range: 80k - 90k

What we offer

• Healthcare
• Prescription drug coverage
• Flexible spending accounts
• Wellness
• Disability coverage
• 401k match
• EAP (Employee Assistance Program)
• Life insurance
• PTO (Paid Time off)
• Holidays

Gerresheimer/Centor is an Equal Opportunity Employer and affords equal opportunity to all applicants and employees for all positions without regards to race, color, religion, sex national origin, age, disability, veteran status, or any other legally protected status in accordance with applicable federal, state, and local laws.