- Reference: CJ43627
- Job Type: Contract
- Location: Cork, Cork city, Munster
- Category: Engineering, Technical & Manufacturing
The successful candidate will scope, design, plan, execute, commission and qualify modern high technology equipment / processes for the manufacturing, control and testing/inspection of bulk & speciality drug products. He/she will also provide engineering support to ensure we meet the highest Engineering, EHS and Quality Standards.
Role & Responsibilities:
- Complete front end studies for Capex Projects
- Introduce new equipment / processes / technologies for existing and new product introduction, from design through C&Q
- Completion of projects in line with Corporate Engineering, EHSE & Quality Standards, and Regulations
- Liaising with other departments to successfully deliver engineering projects, to meet stakeholder expectation
- Responsible for ensuring allocated projects are completed to agreed timelines and within budget.
- Supervise project works performed by external vendors
- Facilitates collaborative project delivery with Manufacturing, Finance, Supply Chain, Engineering, EHSE and Quality.
- Responsible for the design, commissioning, qualification and handover of process packages to end-user departments
- Maintain accurate and complete product and project documentation in accordance with cGMP, EHSE Regulatory requirements and electrical, mechanical & automation standards
- Participate on Safety, Quality and IT Project Risk Assessments
- Bachelor degree in Engineering essential. B.Sc. degree in Process; Chemical; Mechanical; Electrical Engineering or other related discipline.
- Knowledge of project and process engineering, equipment, automation specification and GMP validation requirements.
- 3-8 years + experience in high volume manufacturing environment with experience of process engineering and equipment validation.
- Knowledge of machinery directive CE marking advantageous
- PC and software proficiency – Microsoft software and Microsoft project
- Strong project experience and proven ability to influence others are essential.
- Must have excellent written and verbal communication skills
- Proven track record working as part of a fast paced dynamic project team
- Experience of current cGMP requirement for an FDA/HPRA approved facility
- Experience working on validated systems
: Yes, 10 % of the Time
For a confidential discussion and more information on the role, please contact Kaylie O’ Brien on 021 4911064 or email firstname.lastname@example.org
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
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