This position will be part of BTx Pharmaceutical Research & Development supporting their global locations in the US and the UK. The role will be reporting within the India GRS organization. The incumbent will lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle. They will interact with cross functional development teams working with all levels of employees. Light technical writing and editing expected, applied to regulatory documents and supportive scientific / technical reports.  Attention to detail, particularly for verification of data integrity, is crucial. The colleague must work within established corporate and organizational guidelines and must record and document all relevant information.  The colleague must be able to thrive in a fast-paced environment and to interact effectively with peers and senior scientists & engineers as part of a multi-disciplinary global team. 

Job Responsibilities:

• Ensures that combination product development activities are compliant with quality and regulatory standards – both internal and external.  
• Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.  
• Provide input and support for design validation, including but not limited to human factors engineering assessments.   
• Support the generation of all regulatory submission data and content for assigned device projects. 
• Author documents that will be a part of the Design History File
• Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply. 
• Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture. 
• Support internal and external audits of the DPDD Quality System. 

Qualifications

Preferred Education:

BS degree in appropriate Science/Pharmacy/Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 4-6 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries. 

OR  

MS degree in appropriate Science/Pharmacy/Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering; or other related discipline) with a minimum of 3-5 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.  

Preferred Experience:

·       Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive. 

·       Working knowledge of EN 62366 and EU Medical Devices Regulation

·       Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes/injectors, luer connectors, and quality system regulations (Part 4) for combination products  

·       Experience in Design Controls for Combinations Products 

·       Device Risk Management expertise 

·       Understand statistical sampling plan and statistical analysis of test results. 

·       Familiar with Human Factors Engineering - Usability Engineering.   

·       Understand project management methodologies and capable to provide technical leadership for projects. 

·       Familiar with device assembling manufacturing process 

·       Ability to perform mathematical calculations and ability to perform complex data analysis. 

Preferred Attributes:

·       Capable of working independently with minimal supervision  

·       High level of attention to technical details and accuracy. 

·       Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.   

·       Able to work collaboratively in cross functional teams.  

·       Excellent communication (e.g. oral, written, presentation) and interpersonal relationship skills.  

·       Proficiency in general computer software such as word processing, spreadsheets, presentations. 

·       Understand Good Manufacturing Practices (GMP)  

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