Job Description

Why Patients Need You Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

You will provide cleaning validations support for multiple processing areas within API (Active Pharmaceutical Ingredients). You will be responsible for providing procedures and direction to the shop floor in order to ensure that equipment is properly cleaning and released after each campaign. You will possess strong knowledge of API equipment/technologies, API operations, SOPs (Standard Operating Procedures), GMP (Good Manufacturing Practices), standard work and focus on continuous improvement as well as strong organizational, communication, and people skills. As part of the Technical Operations team, you are recognized as a subject matter expert and serve as on-going technical resource to the operating units, overseeing that cleaning is completed within EHS and/or GMP requirements, working to maximize production efficiency where possible. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations. You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Prepare equipment and coordinate between operation team and engineering team on the release of equipment for calibration and maintenance activities in a safe manner.
• Support operation team in planning of energy control and performing of LOTO of equipment to ensure tasks are completed safely and within scheduled duration.
• Perform safety assessment by walkdown with relevant functions to ensure all risks are assessed and equipment are in safe state before releasing for maintenance/modification activities etc.
• Assist in project commissioning, validation activities and shutdown activities.
• Coordinate with vendors or contractors for day to day and/or during shutdown tasks as necessary.
• Update status for calibration using application for e.g. EAMS, on preventive maintenance work in a timely manner.
• Review Risk Assessment for maintenance or ad-hoc activities in the production areas.
• Participate in HAZOP and PSSR review and close action in a timely manner.
• Report all actual, near misses and potential accidents for further investigation. Assist and provide information to troubleshoot and take initiative to resolve operational issues independently.
• Identify and communicate all operating deviations and problems.
• Complete all required training by attending scheduled training, OJT, JSA, SOP.
• Knowledge in cGMP requirements and complete all documentation according with GMP and GDP standards.
• Develop simple Change Control, execution of change control tasks and follow up CAPA actions when necessary.
• Review and revise relevant Standard Operating Procedure.
• Raise purchase requisition for equipment relevant items.
• Support issuance and reconciliation of Level 1 PDOCS form for operations teams when necessary.
• Stand-in for Day Operations Supervisor in his/her absence.
• Develop courses of action and drive implementation of solutions
• Uphold Pfizer’s code of conduct and values

Qualifications

Must-Have

• Diploma in a technical discipline or GCE ‘A/O’ levels with minimum 5 years relevant experience