Process & Equipment Characterization Engineer

About The Company Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Process & Equipment Characterization Engineer

Location: Ohio

Duration: Long Term

Job Overview We are seeking a Process & Equipment Characterization Engineer with 4+ years of experience in regulated manufacturing environments. The role involves process characterization, equipment qualification, statistical analysis, and troubleshooting of assembly and packaging equipment.

Key Responsibilities

• Perform process and equipment characterization studies, including DOE and process optimization.
• Analyze process data using statistical tools to evaluate process capability.
• Develop and execute IQ/OQ/PQ protocols and reports.
• Verify equipment performance against User Requirement Specifications (URS).
• Troubleshoot equipment issues and perform root cause investigations.
• Develop and update PFMEAs, Control Plans, and technical documentation.
• Support equipment commissioning, installation, and startup.
• Collaborate with Engineering, Quality, Validation, Automation, and Manufacturing teams.

Required Qualifications

• 4+ years of experience in manufacturing, process, or validation engineering.
• Hands-on experience with process characterization, DOE, and process optimization.
• Knowledge of SPC, Cp/Cpk, MSA/Gage R&R, and Minitab.
• Experience with IQ/OQ/PQ and protocol authoring and execution.
• Knowledge of root cause analysis, PFMEA, and Control Plans.
• Familiarity with GMP, FDA regulations, and ISO 13485.
• Experience with assembly or packaging equipment preferred.
• Medical device or pharmaceutical manufacturing experience preferred.
• Strong troubleshooting, analytical, and communication skills.

How To Apply Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.