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Enter your email to apply Requisition ID : MEC000145
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-
year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide.
Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Process Engineer will report to the Technical Engineering Coach and will lie within the Technical Engineering organisation at MSD Carlow.
Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction.
Accountable for analytical / engineering studies associated with the development of new components, products, processes systems and facilities.
Co-ordination, design and execution of equipment qualification. and validation as required.
Serve as technical support for manufacturing and new product introduction.
Design / Author / Review / Approve / Execute process development studies in support of new product introduction and ongoing manufacturing support.
Provide technical input into quality notification by authoring / reviewing / approving investigations.
Execution of equipment / qualification validation programs; including re-qualification and re-validation
Design / Author / Review / Approve / Execute-qualification / validation documentation and studies in line with the standard approval process
Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis
Support continuous improvement through Lean Six Sigma methodologies.
Leading and active participation in projects, system failure investigations and investigation reports,
Execution / development of change controls
Contribution to Kaizen events as appropriate.
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.
g. FMEA, Fishbone diagrams, 5 why’s etc.;
Implement subsequent corrective action through the change management system.
Serve as technical engineering representative for internal technical group discussions and represent Technical Operations Carlow at global technical forums.
Participate and / or lead cross functional or single function teams including liaising with vendors or above site groups.
Drive compliance of MSD Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
Work collaboratively to drive a safe and compliant culture in Carlow.
May be required to perform other duties as assigned.
Education & Experience
Bachelor’s Degree or higher preferred; ideally in a related discipline
Lean Six Sigma Methodology experience required.
Reports, standards, policy writing skills required
Sterile filling processes and equipment an advantage
Proficiency in MS and job related computer applications required
Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes ones department supports.
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.
At MSD, we’re inventing for life.
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