70196
Operations Process Support Specialist
Carlow, Ireland
Engineering
Fix Term Contract
70196
Posted on:
October 7, 2024
The Highlights:
- Working with world leading Pharmaceutical Company
- Excellent professional development and leadership opportunities
- Work with leading edge technology
The Role:
Elusav Recruitment have an exciting openings for a Mechanical Engineer working on Operations Process Support within a Pharmaceutical Company in Carlow.
Job Responsibilities:
- Serve as a technical and operations representative for established manufacturing processes and new product introduction.
- Collaborate within cross-functional teams and partner with colleagues to perform vendor management, communications, training, project work, audit/inspection duties, and ensure department readiness for audits/inspections.
- Design, author, review, approve, and execute process updates in support of ongoing manufacturing support and new product introduction.
- Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
- Drive continuous process improvements using Lean Principles to optimize equipment uptime and target outputs.
- Oversee operations processes to ensure continuous, reliable, and repeatable manufacturing.
- Drive effective writing, revising, and rolling out of accurate operational procedures, training materials, and manufacturing procedures.
- Ensure process reliability and performance by facilitating effective systems for identifying root cause failures, making recommendations, and implementing improvement changes throughout processes.
- Drive continuous improvement by leading and actively participating in system failure investigations, investigation reports, change control execution/development, and Kaizen events.
- Support equipment commissioning and qualification programs representing operations.
- Review and approve qualification/validation documentation and studies.
- Perform data analysis and make informed decisions/recommendations based on the analysis.
- Support continuous improvement through Lean Six Sigma methodologies.
- Lead and actively participate in projects, system failure investigations, investigation reports, and change controls.
- Perform root cause analysis using standard tools and methods to resolve machine and system issues.
- Serve as a technical process representative for internal technical and operations group discussions and represent the company at global technical forums.
- Participate and/or lead cross-functional or single function teams, including liaising with vendors or above site groups.
- Drive compliance with company policies, procedures, and guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
- Ensure compliance through documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactive highlighting of compliance issues.
Job Requirements:
- Bachelors Degree in Mechanical Engineering.
- 1 - 2 Years' experience in a sterile manufacturing environment (GMP).
- Strong troubleshooting and problem solving capabilities.
If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on stephen@elusav.com or +3536959993.
Apply Nowyou are applying for the role of
Operations Process Support Specialist
Latest Vacancies
Browse all jobs
Subscribe to our newsletter!
Join our newsletter and receive leading industry insights and Job Opportunities, straight to your inbox.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
