Operations Engineer

Tipperary, Ireland | Posted on 12/20/2024

- 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 clients’ expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Operations Engineer

Reports To: API Production Leader.

Job Purpose: Reporting to the API Production Leader, the Operations Engineer provides day-to-day engineering support to the site.

Requirements

Principal Accountabilities:

- Acts as primary delegate for the Production Leader.
- Provides on-the-floor technical support to the Shift Manager.
- Alarm investigation and troubleshooting.
- Attending daily handover.
- Day-to-Day troubleshooting.
- Provides technical/operational expertise on continuous improvement projects.
- Mentors engineers in the Process Technical Group in equipment and operations so they achieve more hands-on knowledge.
- Provides support to meet production and turnaround schedules through coordination and escalation of key activities through the Tier System.
- Acts as an Operations Representative in improvement project teams in the areas of Safety, Environmental, and Quality.

Monitoring

- Uses appropriate tools to monitor and complete statistical analysis on:
- Alarm management.
- RTO start-up, shutdown, and PM.
- Update of the vent header.
- Review of venting strategies for NPI’s.
- Monitors critical equipment performance for reliability, recurring failures, and uptime to identify root cause.
- Monitors critical IPT metrics to identify trends and differences between actual and expected performance.
- Completes ongoing monitoring of project control phase metrics to ensure benefit realization.
- Monitors turnaround in real time to identify recurring issues or differences between expected and actual performance.
- Reviews recurring and significant deviations to identify common themes for continuous improvement actions.
- Continuous Improvement through LSS.
- Using the data generated from the above monitoring activities, and an extensive knowledge of available LSS tools (e.g., Kaizen, Deep dive, DMAIC, Process Mapping, 5S, etc.), identifies and implements continuous improvement initiatives on critical site processes and systems in real-time.
- Involves the appropriate site personnel in the continuous improvement initiatives, with particular emphasis on the end-users (i.e., Operators, Lab Technicians, Team Leaders, M&I technicians, etc.).
- Implements appropriate controls to sustain benefits achieved in all continuous improvement activities.
- Facilitates expanded involvement in the site LSS program to all levels of the organization.

Special Features:

- The incumbent plays a key leadership role and must combine expert knowledge in manufacturing operations with good leadership ability. The incumbent must be self-motivated and have a proven track record in Operations. It is envisaged that the incumbent have a minimum of 3 years site experience ideally having 2 years working experience.
- Continuously identifies opportunities for improving productivity to facilitate better than profit plan performance during the production year and increasing the site's capacity for future years.

Core Competencies

Technical:

- Must possess skills and knowledge in the following areas:
- Extensive change management knowledge.
- Detailed understanding of Manufacturing Operations.
- Detailed knowledge of Quality Policies and procedures relevant to responsibilities.
- Detailed knowledge of Good Manufacturing Practice.
- Process chemistry/engineering.
- High level of knowledge of Safety and Environmental requirements.
- Detailed plant and equipment knowledge.
- Organization and planning skills.

Business:

- Personnel and equipment resource management.
- Develop financial forecasts and adhere to yearly budgets.
- Identify cost-saving opportunities and implement cost reduction projects.
- Drive improvements in production yields.

Leadership:

- Must demonstrate the necessary leadership skills as follows:
- Principle centered Leadership.
- Interpersonal Skills, particularly an ability to deal with people at all levels in the organization.

Proactivity:

- Ability to involve and influence others in change execution.
- Ability to make decisions under pressure.
- Ability to lead cross-site project teams.
- Drive focus to meet production deadlines and targets.

Educational Requirements:

- B. Eng Degree in Chemical and Process Engineering.
- Minimum 3 years industrial experience.
- Lean Six Sigma Certification required – minimum yellow belt certification.

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