Job Title: Sr. Manufacturing Automation Engineer
Location: Westbrook, Maine, United States
Employment Type: Contract
Duration: Long Term
Job Summary:
The Sr. Manufacturing Automation Engineer will support manufacturing operations within an infectious disease diagnostics business unit. This role focuses on automation, process improvement, equipment optimization, and compliance with cGMP, FDA, and ISO standards. The position involves leading cross-functional initiatives to improve quality, efficiency, and reliability of manufacturing systems while ensuring regulatory compliance and workplace safety.
Responsibilities:
Ensure compliance with company policies, procedures, and applicable regulatory requirements (FDA, ISO, cGMP).
Support and improve manufacturing processes, focusing on automation, quality, and cost efficiency.
Lead automation equipment upgrades related to safety, obsolescence, and continuous improvement.
Troubleshoot equipment, including machine logic, electromechanical systems, and process controls.
Perform root cause analysis and implement corrective and preventive actions (CAPA).
Conduct Failure Modes and Effects Analysis (FMEA) and risk assessments for manufacturing equipment.
Design and execute experiments (DOE), validation protocols, and data analysis; present findings to stakeholders.
Evaluate and improve manufacturing equipment and processes for performance and reliability.
Develop and maintain technical documentation including SOPs, validation protocols, specifications, and work instructions.
Lead cross-functional teams and manage project timelines, deliverables, and communications.
Provide technical training and mentorship to engineers and technicians.
Collaborate with Project Management Office (PMO) on project milestones and updates.
Support process development, tooling, cleaning validation, and process characterization activities.
Drive continuous improvement using Lean Six Sigma or similar methodologies.
Ensure designs consider safety, ergonomics, maintenance, and operator usability.
Required Qualifications:
Bachelor's degree in Engineering or a related field, or equivalent combination of education and experience.
7+ years of engineering experience in a manufacturing environment.
Experience with Lean Six Sigma, DMAIC, or structured problem-solving methodologies.
Knowledge of change management processes.
Strong troubleshooting and analytical skills in automation and manufacturing systems.
Work Requirements:
Ability to work on-site in Westbrook, Maine.
Ability to collaborate across cross-functional teams and communicate effectively with stakeholders.
Ability to manage multiple projects and priorities in a regulated manufacturing environment.
Must comply with all workplace safety requirements and company policies.
May require occasional extended hours based on project needs.
Salary/Rate: $50.00 $55.00 per hour (This range represents a good-faith estimate based on the job location, required experience, and market conditions. Actual compensation may vary based on qualifications, experience, and other factors permitted by law.)
Benefits: This is a contract position. No employer-provided benefits are offered unless otherwise required by applicable law.
Equal Opportunity Employer:
The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local laws.
Application:
Interested candidates should apply with an updated resume that highlights relevant experience and qualifications. Applications will be reviewed in accordance with applicable laws, and only qualified candidates will be contacted for further consideration.