- Reference: GY44234
- Job Type: Permanent
- Location: Galway, Galway City, Roscommon
- Category: Engineering, Technical & Manufacturing
Set up a new Manufacturing Process.
Manage the successful scale up and commercialisation of this new process ensuring that target yield, capacity, throughput time and productivity are achieved.
- Design, procure and construct “Lean” production lines taking into account flow optimisation, throughput time, product movement, layout and space.
- Specification, Procurement, Installation, and Validation of Manufacturing Equipment. This will include on site Factory Acceptance Testing of equipment.
- Set up Preventive Maintenance and Calibration routines.
- Lead the knowledge transfer of this new manufacturing process and provide training to product builders and technicians.
- Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance. Effectively trouble shoot issues implementing “robust permanent fix” solutions.
- Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs.
- Set up and order Product, Components, Consumables, and Material necessary for validation and production.
- Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
- Generate and gain approval for project budgets and subsequently manage expense and capital expenditure in line with this budget.
- Partner with R&D, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective
- Engineering Degree or equivalent.
- A minimum of 3 years’ experience in a similar role
- Strong technical understanding of set up and maintenance of manufacturing processes, experience in validation, equipment design and Lean Manufacturing highly desirable.
Competencies and Attributes
- Demonstrated expertise and detailed knowledge of the medical device industry and in particular combination medical devices. Familiarity with Drug and other Coating techniques.
- Experienced in Product Transfers and Manufacturing process set-‐up and scale-‐up.
- Equipment Procurement and Validation experience.
- Proven technical expertise and competence across all aspects of Manufacturing Engineering function including lean.
- Has prepared SOPs, conducted IQ/OQ/PQs and/or validations previously in a regulated environment.
- Effective knowledge of the regulatory environment in which the business operates.
- Proven written and oral communication skills and an ability to prepare competent business cases.
- An analytical approach to problem solving.
- Oral communication skills and capacity to represent the company to customer and representatives of regulatory bodies.
- Is creative, continually learning and exploring new ideas.
- High level of flexibility required with regard to role and prioritisation of activities
- A self-‐starter applies his/her own initiative in most situations.
- A good team player who works well in a small team environment.
- Capacity to maintain the highest levels of confidentiality internally and externally.
- Ability to stay connected to multiple projects simultaneously.
Contact ConsultantRequest a Call Back
view salary guide
Collins McNicholas were delighted to present Pieta House with a cheque for €6,000 in January this year. We raised this money over the course of 2016 through a series of events, which included table quizzes, coffee mornings, and a sponsored skydive to be held at the start of April. We are proud to support […]read whole article
Collins McNicholas has been named as one of Ireland’s ‘Best Managed’ companies in the Deloitte Best Managed Companies Awards Programme. The company, which demonstrated superior business performance for the fourth year running, was recognised at an awards gala dinner in Dublin on 3 March 2017. The awards event in Dublin’s Convention Centre marked the ninth […]read whole article
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