Equipment Engineer

• Specify, procure, test, install, and implement new manufacturing equipment, with a strong focus on packaging equipment
• Support aseptic blow-fill-seal and packaging lines through validation, start-up, and continuous process improvement
• Create drawings for equipment tooling and package materials used in manufacturing
• Write and facilitate approval of user requirements, change-control documents, design specifications, and acceptance-test documents
• Develop and maintain project plans and manage equipment-related projects from inception through closeout
• Compile, develop, and maintain an equipment specification library using project experience and lessons learned
• Prepare requests for quotation, review bids, and recommend vendors for equipment projects
• Define, evaluate, and communicate equipment requirements to technical and non-technical audiences
• Troubleshoot technical, machine-based manufacturing issues
• Provide periodic after-hours and weekend engineering support for 24x7 operations
• Develop strategic automation plans to improve manufacturing efficiency and reduce costs
• Travel up to 10% for Factory Acceptance Testing and to identify appropriate equipment
• Maintain relevant Quality System components
• Identify, evaluate, and manage risk to ensure product quality
• Communicate risk policies and processes throughout the organization
• Perform other duties as assigned

• Bachelor of Science degree in Mechanical Engineering, Electrical Engineering, or an equivalent technical discipline and experience
• At least five years of Equipment Engineering experience required
• Knowledge of change control and validation principles desired
• Experience with packaging equipment in the pharmaceutical, food, or cosmetic industry is a plus
• Experience with pouching equipment, cartoners, labeling equipment, scanners, and vision systems is a plus
• Experience working in a cGMP-controlled environment
• Six Sigma, Lean Manufacturing, or professional project-management experience is a plus
• Demonstrated intermediate mathematical aptitude and strong mechanical aptitude
• High level of attention to detail and excellent documentation skills
• Strong written, verbal, analytical, problem-solving, and communication skills
• Proficiency with business computer applications, including word processing, spreadsheets, and database software
• Ability to interact effectively with suppliers, internal managers, and senior management
• Ability to work independently on multiple projects and contribute effectively in a team environment
• Ability to interpret written, oral, diagram, and schedule-based instructions
• Ability to perform timely risk assessments and act accordingly
• Familiarity with cGMP principles and safe work practices, with the ability to quickly learn and apply them
• Willingness to share knowledge, listen actively, simplify processes, act ethically, and drive improvement
• Ability to read, write, and speak clear English
• Ability to stand for up to 10 hours per day
• Frequent sitting, standing, walking, climbing ladders or steps, reading, computer use, reaching, stooping, kneeling, crouching, talking, listening, writing, and bending
• Occasional walking on inclines or uneven terrain, balancing, and carrying
• Frequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds
• Ability to use protective equipment and maintain awareness of personal safety and the safety of others

Demonstrates expertise in Equipment Engineering with a focus on packaging equipment, including proficiency in change control, validation principles, and project management. Capable of developing strategic automation plans and maintaining compliance with cGMP standards while effectively communicating technical requirements.

• Equipment Engineering Experience
• Packaging Equipment Knowledge
• CGMP Compliance
• Six Sigma Certification
• Project Management Skills

• Mechanical Engineering
• Electrical Engineering
• Change Control
• Validation Principles
• Project Management
• Mathematical Aptitude
• Technical Troubleshooting
• Risk Assessment
• Documentation Skills
• Automation Planning

• Attention to Detail
• Analytical Skills
• Problem-Solving Skills
• Communication Skills
• Team Collaboration

• Six Sigma
• Lean Manufacturing

• CGMP
• Pharmaceutical Industry
• Food Industry
• Cosmetic Industry
• Aseptic Blow-Fill-Seal

• Business Computer Applications
• Word Processing Software
• Spreadsheet Software
• Database Software
• Packaging Equipment