Automation / Software Quality Engineer (Dublin)
kppm are currently looking to recruit an Automation / Software Quality Engineer to join the Automation team of our client a large pharmaceutical manufacturing company based in Dublin South West.
The successful candidate will provide quality compliance and validation support to Engineering and the Automation Department on computerized and automated processes.
Qualifications & Key skills:
Suitable applicants must have a 3rd Level degree in Science or Engineering plus a minimum of 3+ years experience in an Automation or Quality role plus:
- Pharmaceutical Manufacturing Industry experience
- GAMP 5 exposure.
- High level understanding of controls systems, SCADA, controllers,etc.
- Validation/Qualification exposure with a quality mindset , using quality management systems
- Strong problem-solving skills including Leading A3 processes.
- Ability to motivate & influence peers.
- Be able to build partnerships & work collaboratively with others to meet shared objectives.
- Strong communication skills including written and verbal skills.
- Competent understanding of regulatory guidelines.
- Be innovative, by creating new & better ways for the organisation to be successful.
- Have a strategic mindset, seeing ahead to future possibilities & translating them into breakthrough strategies.
- Drives results; motivated by success and passionate about working and achieving higher results. Persists to complete tasks / responsibilities, even in the face of difficulties.
- Self-starter with ability to complete work independently as well as successfully lead others if needed.
- Ability to work well with other technical staff in a collaborative, fast-paced goal-driven environment
- A “can do” attitude and genuine enthusiasm for driving improvements
- A positive mindset of Safety First
Key responsibilities would include (but are not limited to):
- Responsible for tracking the Department’s metrics.
- To provide quality compliance and validation expertise in relation to the qualification of new computerized or automated systems and processes.
- To coordinate department change controls (where required).
- To drive and be responsible for Department deviation investigations and CAPAs (where required).
- To act as a point of contact and as an SQE SME during Internal Inspections of our clients Pharmaceutical Plant in
- To coordinate new Department project initiatives to ensure that they adhere to Validation and Quality requirements.
- To be aware of the latest GAMP 5 and Computerized System Validation guidelines (as appropriate).
- To liaise effectively with all Business Units, in carrying out the above work so that the requirements of each in terms of quality, cost and output are met.
- To follow up on qualification deviations.
- To support software validation activities when required.
- Liaise with Project Engineers to ensure any new or changed instrumentation is completed as per decommissioning/commissioning procedures.
- To promote good Cross-Departmental collaborations.
- To ensure that all work is to the highest standards and in compliance with all requirements i.e. our clients standards, FDA, GMP, GAMP, etc.
- To communicate effectively within the Department and in particular with all stakeholders/ customers.
- Ensure that all Site and Departmental procedures such as PPs, SOPs, WIs and Guidelines etc. are strictly adhered to.
- Pay due care and attention to Health and Safety and Environmental matters.
- To coordinate; write and technically review qualification test packs for computerized or automated systems as required.
- To drive and facilitate problem solving exercises such as A3 RCA investigations.
This is a 12 month fixed term contract rate/salary negotiable depending on experience.
Contact: Tom Doyle at kppm. P: 086 8205038. E: email@example.com
or email firstname.lastname@example.org
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