Shift Process Engineer

**Job Description**:

- Why Patients Need You- Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.- What You Will Achieve- Responsible for leading product manufacturing campaigns from the start of production, and providing technical supervision with respect to quality and EHS until completion and release of the material.- How You Will Achieve It- Develop Manufacturing/Operating Instructions and necessary Standard Operating Procedures.
- Develop, maintain and troubleshoot the process control system recipe/Models.
- Investigate, report and troubleshoot findings on both quality and EHS related issues observed during manufacturing, changeover activities or during batch record review.
- Develop, implement and monitor robust preventive measures for processing issues.
- Play a pro-active role in ensuring the site safety and quality standards are adhered to.
- Proactively monitor, identify, develop and implement improvements in processes and equipment.
- Communicate on a regular basis to the plant personnel on process updates.
- Train the process technicians on the process and procedures as required.
- Ensure adhere to approved procedures and update as required.
- Own one or more multiple equipment/GMP systems in production and present the system overview with evidence compliance to internal and external auditors.
- Provide technical supervision in managing of overall alarm response at OSP control room and ensure alarm response is timely, appropriate and risk assessed as per SOP.
- Record and maintain database for alarm response actions taken by Shift Process Technicians and Panelman
- Review and update the manual interventions for batch processing using DCS log review along with reason for the interventions. This should be done towards the end of the shift so that DCS log for that shift along with other atypical observations are recorded and understood.
- Support shift teams to supervise during batch for any risk assessment requirements for manual intervention/ actions.
- Prepare work documents to support production and changeover activities.
- Perform production batch book and changeover cleaning instructions document review.
- Work with QA to drive document approval to support production and cleaning activities.
- Review and prepare cleaning instructions when required.
- Internal Stakeholders:
- Operation - for supporting operation team to meet production targets in cycle time and output
- Changeover
- Supporting changeover team to meet cleaning activities target timeline
- Supply Chain - for ensuring availability of raw materials for production and supply of finished products to the market, for qualification of alternate source of material/consumables
- Quality - for production batch release and production investigation/improvement and quality related investigation
- Engineering - for equipment readiness and production investigation/improvement
- EHS - for performing safety review of changes in the manufacturing processes and in safety related investigation
- External Stakeholders:
- Equipment Vendors and raw material suppliers - for new materials/equipment/consumables sourcing and during process investigation/improvement
- Qualifications- Bachelor's degree in engineering, preferably in Chemical Engineering or Degree in Science with major in Chemistry
- Preferably, 5-7 years' experience in GMP manufacturing environment.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Engineering

LI-PFE