Manufacturing Process Engineer (Pharma/Chem/EHS/API/PCT), Contract
Summary
· Will be 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.
· Contribute to achieve our vision of being the best in class manufacturing site, producing highest quality products in the safest way.
· Deploy day to day operations, problem solving, escalations and continuous improvements.
Core Competencies:
1. Technical Knowledge
2. Communication
3. Teamwork
4. Leadership
5. Management
6. Creativity & Innovation
7. Self-motivated and independent
RESPONSIBILITIES
· 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 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 adherence to approved procedures and update the procedures as required, including the principles and practices of good data management (ALCOA)
· Focus on Safety and GMP Compliance as operational I priorities and as performance measures
· Account able for the Good Data Management and Data integrity understanding and performance.
· Report and investigate actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
· Own on or more multiple equipment/GMP systems in production and present the system overview with evidence compliance to internal and external auditors.
· Develop courses of action and drive implementation of solutions
· Play an active and impactful role to deliver flawless execution for respective PCTs (e.g. API, MS, 00, Leadership, Engineering) by updating performance against metrics, highlighting & resolving issues with appropriate escalations.
· Work with the PCT to identify and drive improvement as per continuous improvement (CI) goals of the PCT.
· Uphold code of conduct and values
· Senior position is expected to perform coaching role to junior engineers and manage more complex manufacturing and operation issues. He/She is also expected to lead working teams managing projects to support manufacturing processes.
· Collaborate with cross-functional teams to rive flawless execution. Internal Stakeholder includes:
· Operation - for supporting operation team to meet production targets in cycle time and output
· 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
· Engineering - for equipment readiness and production investigation/improvement
· EHS - for performing safety review of changes in the manufacturing processes and in safety related investigation
· Technical Services -for product chemistry, process design understanding, production investigation improvement and product transfer
· External Stakeholders: Equipment Vendors and raw material suppliers - for new materials/equipment/consumables sourcing and during process investigation improvement
Qualifications
Must-Have
· Degree in Engineering, preferably in Chemical Engineering or Degree in Science with Major in Chemistry
· 5'- years of experience in Pharmaceutical / Chemical Plant with sound understanding of API unit of Operations
· Knowledge of Good Manufacturing Practices and experience in pharmaceutical environment
· Experience of project orientated admin/cost control/management
· Broad knowledge of theory and principles within a professional discipline or advanced knowledge of specific technical/operational practices
· Strong technical, management and organizational skills
· Good leadership and communication skills
Nice-to-Have
· Relevant pharmaceutical experience
· Experience in automation including DeltaV and equipment validation
· Knowledge of the manufacturing process and equipment, preferably bacterial fermentation and purification processes
