Associate Manager Process Engineer Job In Pfizer Asia Pacific Pte Ltd In India

Why Patients Need YouPfizer's purpose is to deliver breakthroughs that change patients' lives Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the worldWhat You Will AchieveAs a Scientist, you will be at the center of our operations and you'll find that everything we do, every day, is in line with an unwavering commitment to quality With your deep knowledge in the discipline, you will be an active team member who influences at the project team level.

You will perform qualitative and quantitative analyses of organic, inorganic compounds, or biologics to determine chemical and physical properties during chemical syntheses, fermentation or drug product development processYou will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others Your ability to plan will help in preparing short-term work activities on projects Your creativity in developing novel processes and new ideas will be used frequently You will undertake mentoring activities to guide your team members.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globeHow You Will Achieve It

• Contribute to achievement of goals and influences at the work group/project team level
• Prepare study protocols, Gap assessment, Risk assessment reports, recipe parameter recommendations and CPP requirements in the developed recipe parameters
• Plan and execute for Technology Transfer process including various activities like procurement of equipment's for the developmental, Optimization, Scale up and Exhibit batches
• Prepare and review necessary SOPs / URS/ study protocols / Qualification documents for Developmental/ Technology Transfer activities
• Coordinate with external customers like Filter validation service providers, equipment manufacturers & Vendors etc.
  
  
• Ensure the compliance to cGMP/ cGLP, organizations procedures and practices
• Trouble shooting, ongoing technical support to Manufacturing team for Process validation, Continuous Process Verification and Process improvement
• Technical writing skills
• Actively involve and drive Investigations related to Process engineering and Equipment to evolve CAPAs and monitor the effectiveness of CAPAs Be able to apply DMAIC tool to drive investigation studies
• Communicate progress, plans, requirements and risks to the senior analyst, manager, stakeholders in partner groups and higher management informally and, if required, formally through written reports and presentations.
  
  
• Actively participate and report progress into cross-functional project teams to meet customer expectations, project milestones and Good Manufacturing Practices also cGMP standards
• Prepare and review technical documents, including validation protocols and reports, analytical test procedures, investigation reports, and change controls
• Proficiency on the manufacturing and CIP process using delta V DCS system, SI equipment operation & Maintenance
• Proficient on terminally sterilized equipment train ie formulation process equipment, automation, washer, Tunnel, filling machines, Terminal sterilization, Visual inspection machine (Manual / auto, leak testing by wilco/Nicca) etc.
  
  
• Analyze and communicate experimental results both orally and in written reports to colleagues and management
• Provide the necessary documentation for regulatory submissions as required and writes deficiency responses

QualificationsMust-Have

• Bachelor's Degree
• 6 - 12 years of experience
• Experience with interdisciplinary drug development teams and industrial experience developing analytical strategies and methods in support of product and process development and to assess the quality and characteristics of biotherapeutics
• Experience working in a regulated environment, such as Good Laboratory Practices part of GxP
• Demonstrated technical expertise in functional verification of design
• Working knowledge of applicable industry test standards, relevant regulatory guidance, Design Controls and Product Development Process
• Able to interact effectively with peers and leaders as part of a multi-disciplinary team
• Effective verbal and written communication skills
• Technical writing skills
• Green Belt certified.
  
  

Nice-to-Have

• Master's degree and4+ years of relevant experience
• Exceptional interpersonal skills preferred and a proven track record of teamwork, adaptability, innovation, leadership and initiative

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operatesResearch and Development#LI-PFE

Pfizer Asia Pacific Pte Ltd is looking for .

Pfizer Asia Pacific Pte Ltd is looking for Any Graduate / Post Graduate profile candidates.