Reliability Engineer

Tipperary, Ireland | Posted on 11/29/2024

- Industry: Pharma/Biotech/Clinical Research
- Work Experience: 4-5 years
- Country: Ireland

Job Description

About PSC Biotech

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 points 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 to 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 through learning & development, in-house training, and mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.

Overview:

The SIS Co-ordinator operates in a team-based, continuous improvement environment within the Engineering CoE (Centre of Excellence) and works closely with colleagues from Projects, Automation & IT, Operations, and Maintenance EHS with support from external SME resources to implement improvements to the IEC-61508/IEC-61511 aligned Functional Safety Management System. The SIS Co-ordinator will be the custodian of the Functional Safety Management System at the site. Training and support shall be provided with the role.

Requirements

Responsibilities:

- Act as custodian of the Functional Safety Management System at our site.
- Implement new & revise existing SOPs, Job Aids, Work Instructions, and documentation for our Functional Safety Management System, making use of systems already established.
- Support Functional Safety Life Cycle activities such as:
- Attending HAZOPs and LOPAs where interlocks designed to IEC-61508/IEC-61511 (SISs) are anticipated.
- Provide guidance for SIS Operation, Maintenance & testing best practices.
- Verification activities.
- Organizing periodic FSAs (Functional Safety Assessments) and External Functional Safety Audits.
- Organizing training programs for Functional Safety Management.
- Provide status reports to Management.
- Support other Site Engineering Systems where there are synergies & capacity allows.

Skills & Education Required:

- Bachelor's Degree or equivalent in a relevant Engineering or other Technical discipline or a Trade/3rd level qualification in a related discipline with experience working in a similar environment.
- Preferably 3 years or more experience working in a similar role or a related discipline (Engineering, Calibration, and Instrumentation), preferably in a process plant GMP environment with a strong compliance mindset.
- Experienced in managing Engineering or Maintenance programmes.
- Potential candidates may have some familiarity with electrical & instrumentation operation, maintenance & testing principles along with some understanding of the automation systems they interface with in a processing plant.
- TUV Rheinland or equivalent Certification in Functional Safety is desirable. Otherwise, knowledge and certification for basic Functional Safety is advised. In any case, training and certification will be provided for the successful applicant along with access to support from internal and external SME resources.
- Familiarity with IEC61511 and IEC61508 is desirable.
- Analytical mindset, data-driven with attention to detail on systems and technical documentation.
- Some knowledge of ATEX principles/working in an ATEX plant environment is desirable.
- Good communication skills, decision-making, and problem-solving skills with a proven track record for effectively collaborating, influencing, and working well within a cross-functional team.

Reporting to: API Reliability & Systems Lead

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