SrAssociate Tech Dev Svcs

Use Your Power for Purpose

As a Sr Associate Tech Dev Svcs, you will play a crucial role in improving patients' lives while working at Pfizer. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives.

What You Will Achieve

In this role, you will:

• Manage your own time to meet targets and develop plans for short-term work activities on moderately complex projects.
• Make decisions to resolve moderately complex problems in standard situations, working within guidelines and policies.
• Use your judgment to modify methods and techniques as needed.
• Collaborate with cross-functional teams to ensure project milestones are met.
• Provide technical support and expertise in the development and implementation of new processes and technologies.

Here Is What You Need (Minimum Requirements)

• B-tech ( Chemical Engineering) / equivalent with 8+ years of experience in Process Engineering.
• Strong technical skills in process development and optimization
• Hands on experience in Programming & Operations of DCS systems ( Delta -V)
• Proficiency in data analysis and interpretation
• Experience with project management tools and methodologies
• Knowledge on regulatory requirements and compliance standards
• Ability to work collaboratively in a team environment
• Strong communication skills, both written and verbal
• Proficiency in Microsoft Office Suite
• Provides support for site to site parenteral product transfers by interfacing with cross functional departments across sites.
• 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 API, excipients, equipment's for the developmental, Optimization, Scale up and Exhibit batches.
• Prepare and review necessary SOPs / URS/ Qualification documents for Developmental/ Technology Transfer activities.
• Establish Laboratory to perform design of experiments, developmental batches, feasibility batches, lab scale batches as per plan.
• Technical support to Manufacturing Team for smooth launching of products.
• Prepare Study Protocols and Reports for process development and process optimization etc.
• Coordinate with external customers like Filter validation service providers, equipment manufacturers & Vendors
• Evaluate manufacturing Process and Parameters/ CPPs for Scale up and Exhibit batches manufacturing.
• Ensure the compliance to cGMP/ cGLP, organizations procedures and practices.
• Actively support in execution of Process Validation batches, Equipment Qualifications and validations.
• Trouble shooting, ongoing technical support to Manufacturing team for Process validation, Continuous Process Verification and Process improvement.
• Ensure the compliance to GMP/ cGLP, organizations procedures and practices.
• Develop Continuous Process Verification Protocols and Reports.
• Perform Risk assessment to establish the scope and extent of validation activities.
• Actively involve in Investigations related to Process engineering and Equipment to evolve CAPAs and monitor the effectiveness of CAPAs.
• Understanding on terminally sterilized equipment train i.e. formulation process equipment's, automation, washer, Tunnel, filling machines, Terminal sterilization, ATEC stopper processor, Visual inspection machines.
• Holistic understating on the manufacturing and CIP process using delta V DCS systems.
• Knowledge on new technologies / PAT tools.

Bonus Points If You Have (Preferred Requirements)

• Experience on Process modeling and simulation software like Dynochem etc.
• Exposure towards AI, Machine Learning, Robotics .
• Experience in the pharmaceutical or biotechnology industry
• Familiarity with Good Manufacturing Practices (GMP)
• Experience with statistical software (e.g., Minitab, JMP)
• Ability to lead cross-functional teams
• Strong organizational skills
• Adaptability and flexibility in a dynamic work environment
• Ability to mentor and develop junior team members

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