Senior Mechanical/Electrical Engineer – Pharma Packaging (GMP)

Unither Pharma; City of Rochester (NY); On-site; USD 110,000 - 115,000; Full time

Benefits offered by this job

Medical premiums covered

401(k) match

HSA contributions

Bonus eligibility

Job summary

Unither Manufacturing LLC in Rochester, NY, seeks a Senior Mechanical/Electrical Engineer to lead design, implementation and commissioning of packaging systems. You will work as an SME on filling and packaging lines, coordinate with suppliers, and ensure adherence to specifications and regulatory standards.

The role requires 5–8 years in manufacturing or packaging technology, CAD/P&ID proficiency, and experience in FDA-regulated environments. PMP is a plus; travel may be required.

Qualifications

• 5-8 years in manufacturing environment or packaging technology
• Proficiency in CAD and P&ID diagram creation, editing and review
• Experience in a regulated environment (FDA) a plus
• Strong troubleshooting and problem solving
• Knowledge of packaging equipment operation, vision systems, and validation requirements
• Ability to work in a matrix organization with cross-functional teams
• Ability to specify, procure, oversee installation, and commission systems and processing equipment
• Strong project management skills
• Batch processing, facilities, building utilities and infrastructure knowledge
• Pharmaceutical cGMP requirements knowledge a plus

Responsibilities

• Engage in technical discussions with potential suppliers
• Organize and write specifications based on the needs and requirements (URS)
• Launch calls for tenders (RFP, RFS)
• Ensure the solution designed respects the established specifications
• Document and validate deviations from specifications or internal expectations
• Execute projects within approved deadlines and budget
• Coordinate with external companies
• Propose and apply solutions to mitigate delays
• Proactively alert site management to potential problems
• Ensure successful commissioning of the project
• Monitor installations and commissioning of equipment
• Coordinate suppliers and vendors to health and safety instructions
• Possess technical expertise enabling problem resolution
• Respect data in specifications
• Coordinate with Production to align with production constraints
• Assist commissioning activities and production start-up
• Carry out post-commissioning assessment
• Write feasibility reports, line trials, qualification protocols, test execution and approval reports
• Participate in operator training
• Define training requirements with internal customers and organize with suppliers
• Study technical needs for new site investments
• Participate in project groups and gather internal stakeholder needs
• Define technical solutions and implementations
• Respect technical, regulatory and quality requirements from Management and QA
• Consider parameters like water, energy, and safety constraints
• Ensure documentation of completed projects is updated
• Collect vendor technical drawings and reflect them in the final design

Skills

CAD proficiency

P&ID diagram creation

Problem solving

Cross-functional teamwork

Education

Bachelor’s degree in Mechanical or Electrical Engineering

Master’s degree considered a plus

Tools

PMP a plus

Job description

Unither Manufacturing LLC in Rochester, NY, seeks a Senior Mechanical/Electrical Engineer to lead design, implementation and commissioning of packaging systems. You will work as an SME on filling and packaging lines, coordinate with suppliers, and ensure adherence to specifications and regulatory standards.

The role requires 5–8 years in manufacturing or packaging technology, CAD/P&ID proficiency, and experience in FDA-regulated environments. PMP is a plus; travel may be required.