What are the responsibilities and job description for the Manufacturing Execution Systems Professional position at Lonza?
Job Description
This MES Automation Engineer Level 3 role is a critical member of our team, responsible for creating and maintaining MES authoring principles and practices at our Lonza site in Portsmouth, NH.
The position ensures consistent and innovative design and implementation of MES solutions across projects and processes, ensuring seamless integration with existing infrastructure.
Key Responsibilities:
- Safety: Perform all work safely, meet training requirements, develop technical knowledge on manufacturing equipment and process automation systems.
- Resolution of Equipment Breakdowns: Resolve all equipment breakdowns and quality issues in the suites.
- MES Engineering Lead: Act as MES engineering lead for tech transfer of new processes into the facility.
- Change Request Assessments: Complete change request lot assessments to support lot release.
- Audit Participation: Participate in audits and inspections as MES SME.
Project Deliverables:
- Plant Projects: Plan and execute plant projects involving complex automation changes and significant process improvements.
- Test Script Execution: Execute test scripts (design, execution, simulation, wet testing) to validate system performance.
- Change Request Management: Own change requests and complete change request tasks to support project completion.
- Project Assessment: Perform change request assessments and provide recommendations for improvement.
Collaboration and Support:
- Deviation Investigations: Assist the Quality department with deviation investigations.
- MES Review/Approval: Perform MES review/approval of deviations.
- Quality Risk Assessments: Participate in RCAs as MES representative.
- CAPA Actions Execution: Own and execute completion of CAPA actions.
- Action Plan Approval: Approve action plans for non-regulatory CAPA.
Documentation and Compliance:
- MES and Manufacturing SOPs Review: Review/revise MES and Manufacturing related SOPs, Functional Specifications, and work instructions.
- Batch Records/MES Review: Complete MES review/approval of batch records, deviations, commissioning protocols, and validation protocols.
Additional Responsibilities:
- Recruitment Assistance: Assist in department recruiting efforts as an interviewer.
- Mentorship: Mentor less experienced engineers in the group.
Requirements:
- Education: Bachelor's degree in an engineering or related discipline with 5-10 years of automation experience.
- GMP Experience: Related work experience in a GMP environment.
- Communication Skills: Strong communication and leadership skills.
- Problem-Solving Ability: Ability to evaluate engineering problems and propose solutions.
- On-Call Hours: Ability to fulfill on-call hours requirements.
We are committed to ethical business practices and respect our people and the environment.
