Job Description About PSC Biotech Who are we?
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 point 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 of 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 though Learning & Development in-house training mentorship through constant guidance to facilitate career progression.
We believe in creating high performing teams that can exceed our client's 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 Leaders, including: 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 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 Environmental daily support, troubleshooting & enhancements.
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 realisation.
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.
Proprietary 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 organisation.
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 minimum 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 sites 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 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.
Computer skills including word processing, spreadsheets, MIDAS, SAP, MES, Pi.
Business: Plan production schedules.
Personnel and equipment resource management Develop financial forecasts and adhere to yearly budgets.
Proprietary: Identify cost saving opportunities and implement cost reduction projects.
Drive improvements in production yields.
Leadership: Must demonstrate the necessary leadership skills as follows: Problem solving skills.
Communication skills.
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.
#LI-BR1 Requirements Must possess skills and knowledge in the following areas: Extensive change management knowledge Detailed understanding of Manufacturing Operations.
Detailed knowledge 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.