Maintenance Engineer - Ireland - PSC Biotech

Description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• Country Ireland

Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Maintenance Engineer

Role Function:

· Responsible for Maintenance and calibrationexecution and continuous improvement. Ensure that objectives are effectivelyachieved, consistent with client's requirements to ensure compliance, safetyand reliable supply to our customers.

· Ensure that all Planned Maintenance andCalibration are complete to the schedule. Collaborate with equipment ownersother departments, particularly Quality, EHS, Technical Operations, incompletion of tasks to ensure best practice outputs e.g. partner withvalidation, maintenance and production operators in the investigation ofequipment performance issues. Work under the guidance of the Coaches andMaintenance Sustaining Engineers to apply lean tools to process data in orderto complete improvements.

· Manage process / equipment improvements throughcompletion of projects as required. Responsible for delivery of training, whilefocusing on continuous process improvement using Lean Principles. Maximisingequipment uptime

· Troubleshoot equipment problems, identify needfor new equipment and/or modifications to existing equipment to optimizethroughput and reduce process cycle times; Drive change through Change controlsystem in line with deadlines.

· Serve as the point-of-contact for new equipmentand/or modifications to existing equipment.

· Provide support with audit/inspectionrequirements to ensure department compliance/readiness.Participate in internal and external auditsand inspections.

· Drive continuous improvement, perform root causeanalysis on system failures and substandard equipment performance, usingstandard tools and methods, to resolve machine and system issues e.g. FMEA,Fishbone diagrams, 5 why's etc, all under aseptic/clean room conditions.Provide input, review and approval for atypical, observation, and processcapability investigations. Oversee coordination of resources to implementsuggestions/ideas of merit.

· Recognize and investigate opportunities forfinancial savings and supports opportunities for financial savings by providingresources, expertise and project work; Participates in development of profitplan and budgets. Reduce maintenance costs and improve the overall equipmenteffectiveness.

· Drive and participate effectively inwriting/revising/ rolling out accurate operational procedures, trainingmaterials and maintenance procedures for various IPT systems; ensure all workis carried out in line with same.

· Leadership activities including selection,development, coaching and day to day management. Ensure that the team receivesappropriate resources and programmes to develop technical and other skills, tocomplete their jobs whilst stimulating personal growth and development in linewith role.

· Required to comply with Merck Global Policies,Procedures and Guidelines, regulatory requirements and execute current Goodmanufacturing Practices (cGMP) in the performance of day to day activities andall applicable job functions.

· Work collaboratively to drive a safe andcompliant culture

Requirements

Skills and Knowledge:

· Bachelors Degree or equivalent; ideally in arelated Science, Engineering or other Technical discipline

· Minimum of 3 years relevant experience inmaintenance engineer / engineering role within a maintenance / engineering orgof manufacturing facility (preferably GMP)

Core Competencies:

Technical:

· Knowledge of regulatory/code requirements toIrish, European and International Codes, Standards and Practices

· Sterile filling processes and equipment

· Knowledge in Autoclaves, Washers, SKIDS, Vesselsis an advantage.

· Understanding of mechanical/electrical/pneumaticprocesses

· Troubleshooting and maintaining processinstrumentation and equipment

· Proficiency in Microsoft Office and job relatedcomputer applications required

· Knowledge of cGMP and GDP preferred

· SAP knowledge and experience preferred

· Report, standards, policy writing skillsrequired

Business:

· Excellent communication, presentation andinterpersonal skills, to interface effectively with all levels of colleaguesand with external customers in a team orientated manner

· Understand the specific responsibilities of alldepartments as they relate to ones own department, understanding the businessprocesses ones department supports

· Self motivated

· Strategy planning and development

· Effective time management and multi-taskingskills