Engineer ProQN844

ProQuality Network; Northern (KY); On-site; USD 75,000 - 105,000; Full time

Job summary

ProQuality Network in the United States seeks an Engineer to support process optimization, troubleshooting, and engineering projects in a highly regulated pharmaceutical/biotechnology environment. The role emphasizes applying engineering principles to operational challenges and project work.

Ideal candidate has an engineering background, strong analytical and problem-solving skills, and ability to work with cross-functional teams while maintaining quality and compliance.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 2 years of engineering experience in manufacturing or process environments.
• Strong analytical and problem-solving abilities.
• Familiarity with GLP/GMP and validation concepts.

Responsibilities

• Support process optimization and troubleshooting within operations and manufacturing.
• Apply engineering principles to system modifications and capital projects.
• Analyze operational data and present interpretations and recommendations.
• Provide solutions to technical problems of moderate scope and complexity.
• Collaborate with cross-functional teams including Research, Manufacturing, Maintenance, Quality Assurance, and Validation.

Skills

Process optimization

Troubleshooting

Analytical skills

Problem solving

Engineering principles

Data analysis

Technical writing

Education

Bachelor's degree in Engineering

2 years engineering experience

Job description

Schedule: Administrative Shift, with availability to support non-standard shifts based on business needs

Position Summary

Our client is seeking an Engineer to support process optimization, troubleshooting, manufacturing operations, and engineering projects within a highly regulated pharmaceutical/biotechnology environment.

The ideal candidate will have an engineering background, strong analytical and problem-solving skills, and the ability to apply engineering principles to operational challenges, system modifications, validation activities, and projects of limited to moderate scope and complexity.

Key Responsibilities

• Support process optimization and troubleshooting activities within operations, manufacturing, pilot plant, or capital project environments.
• Apply engineering principles to support system modifications, experiments, and capital projects.
• Analyze operational and engineering data and present clear interpretations and recommendations.
• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate and apply standard engineering techniques and procedures under general supervision.
• Complete routine technical assignments and investigations involving a limited number of variables.
• Serve as a technical resource for equipment and systems troubleshooting.
• Support daily operations when needed to meet schedules or resolve complex technical issues.
• Assess the operational performance and regulatory compliance of equipment and systems.
• Collaborate with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams.
• Support the development of requirements and recommendations for system modifications.
• Assist project managers with design, engineering, and construction projects while maintaining schedule and budget requirements.
• Collaborate with consultants, architects, and engineering firms on standard design documentation.
• Review and evaluate quotes for equipment modifications or installations.
• Prepare basic project cost estimates and schedules.
• Perform additional functions as assigned based on business needs.

Preferred Qualifications

• Chemical Engineering background preferred.
• Experience with Statistical Analysis.
• Biotechnology industry experience is a plus.
• Experience with Drug Substance Manufacturing or technical support is a plus.
• Working knowledge of pharmaceutical/biotechnology processes.
• Familiarity with validation processes and validation protocol execution.
• Familiarity with documentation requirements in a highly regulated environment.
• Ability to interpret and apply GLP and GMP requirements.
• Ability to apply engineering principles to manufacturing operations.
• Experience developing solutions to routine technical problems.
• Ability to operate specialized laboratory equipment and computer systems as required.
• Strong problem-solving and applied engineering skills.
• Basic technical report writing and presentation skills.
• Strong personal organization and ability to manage change.
• Familiarity with validation protocol writing.
• Strong analytical problem-solving skills and computer literacy.
• Technical knowledge related to equipment and systems.

Education & Experience

• Bachelor’s degree in Engineering with 2 years of engineering experience.

Interested candidates: Please submit your updated resume through ProQuality Network or contact our recruiting team for consideration.