Changeover Specialist | Collins McNicholas

Changeover Specialist

  • Reference: CJ44965
  • Job Type: Contract
  • Location: Cork, Cork City, Munster
  • Category: Science, Pharmaceutical & Food

Job Description:

The change-over of equipment trains from product to product is a key activity for the site; change-overs must be planned for and executed adhering to the site’s fundamental strategies of Safety, Quality, Supply and Cost. Excellence in the safe and efficient change-over of equipment trains from product to product plays a key role in the delivery of products to the markets. The change-over is divided into two sections, namely the PostMI and the PreMI.

 

Responsibilities:

  • Co-ordinate the PostMI activities in a multi-product manufacturing facility.
  • Take ownership of Post-MI section of the change-over to ensure Post-MI is executed to the required safety standard and delivering audit readiness
  • Provide process technical support in order to sustain & improve the changeover processes on site
  • Coordinate all GMP aspects of the postMI, ensuring the required documentation is in place prior to the start of the change-over, ensuring 100% Manufacturing Right First time during the postMI and implementing sustainable CAPAs following any deviations.
  • Using Right First-Time tools, trouble-shoot and provide sustainable solutions for root cause problems.
  • Work closely with the Operations, Safety, Engineering, Quality Operations and Value Stream Teams to ensure change-overs are executed with zero SIIs and zero defects
  • Identify hazards, assess their relative risk and incorporate recommendations into your   designs of the postMI train.
  • Effectively use the site business processes to support and to monitor the postMI process e.g. change control, deviations, 6 sigma Method 1 investigations, Area Information Centers etc.
  • Work with the Change-over team in leading in the implementation of key change-over projects for the site, targeted at reducing the sites change-over time.
  • Align change-overs to Standard Work Plans and lead other Lean initiatives to reduce the overall change-over time on site

 

Experience Required:

  • A relevant 3rd Level qualification and/or significant experience in a pharmaceutical environment.
  • A demonstrated ability to proactively problem solve solutions to Engineering and Quality scenarios.
  • Excellent people and communication skills working in a cross functional team environment.
  • Will have the initiative and creativity to identify improvement opportunities and work to see them implemented.
  • Strong planning and organisational skills and a proven ability to deliver against timelines.
  • A proven knowledge of GMP procedures and the requirements of change controls, Standard Operating Procedures, document control, etc.
  • A willingness to learn and be challenged.
  • An ability to deal with process change and to implement new and effective processes.
  • Demonstrated applications of Lean and Six Sigma tools will be an advantage.

 

Core Competencies for the role:

  • Acts Decisively.
  • Seizes Accountability.
  • Change Agile
  • Peer Relationships
  • Grows Self
  • Self-Awareness.

For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911063 or email eloisa.ruiz@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!

 


Firstname (required)

Surname (required)

Your Email (required)

Your phone

Upload CV (required)

Security Code captcha

Comment

Contact Consultant

  • Eloísa Ruiz
  • Recruitment Consultant
  • 021 4809 118
  • Connect with Eloísa
Request a Call Back

Half-Way Point Shows Positive Employment Trends for 2017

Positive labour market pic
Collins McNicholas has seen a 6% growth in registered job vacancies in the first half of 2017 compared with the first half of 2016. The number of candidates registered with Collins McNicholas is up by 24% in the same period. The growth in jobs shows a buoyant job market with candidates willing to switch jobs […]
read whole article

Job Seekers Guide

cmcn_hr_color
Everything you need to know to find a job, including; how to prepare a CV and cover letter, how to prepare for a job interview, how to navigate the modern job market, and much more.
view more