Why Patients Need You
Pfizer'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. In your role you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.What You Will Achieve
When you join Pfizer, you'll be joining a company and team with a desire to bring new, cutting edge medicines to patients around the world. This position will be part of BTx Pharmaceutical Research & Development located at Andover, MA. You will lead human factors engineering activities for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle and will interact with cross functional development teams working with all levels of employees.
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. You will be recognized as a technical expert and a scientific contributor. With your deep knowledge of the discipline, you will be an active team member who influences at the project team level. You 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 dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
- Lead human factors engineering activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
- Provide device usability input/support to device design inputs and device design specification
- Author, manage, approve and maintain support for use related risk management activities related to assigned devices
- Assist with all design validation activities for assigned projects including clinical study support, complaints analysis and author justifications for not performing human factors where applicable.
- Support all human factors (HF) activities associated with HF vendors, including on boarding of HF vendor, generation of study brief, attainment of HF vendor proposals, assignment of HF vendor, providing all relevant materials and documentation, management of HF studies, and generation and approval of associated reports
- Support project management of the supply, assembly and testing of materials for use in HF studies and associated documentation, ensuring timely execution of HF studies for assigned projects
- Provide HF study feedback and/or recommended mitigation actions into the DPDD project team and external device design authorities where appropriate
- Provide input and support for generation of assigned Pfizer device Instructions for Use (IFU), device labelling and packaging
- Design and ensure full change control for IFU documentation where applicable for assigned projects
- Support the generation of device regulatory submission data and content for assigned device projects
- Support and conduct human factors research to augment present and future device projects including in-house laboratory testing and external research with the support of contract staff/vendors
- Support continuous improvement activities as they relate to design validation/human factors
- Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
- Support internal and external audits of the DPDD and DCoE Quality Systems as they relate to design validation/human factors.
- BS degree in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering, Human Factors, Ergonomics, Industrial Design; or other related discipline) with a minimum of 3-5 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries, OR
- MS degree in appropriate Science & Engineering discipline (Chemistry, Biochemistry; Biomedical, Mechanical, Materials, Chemical Engineering, Human Factors, Ergonomics, Industrial Design; or other related discipline) with a minimum of 2-4 years of relevant experience in the Pharmaceutical Combination Product and/or Device industries.
- Working knowledge of ISO 9001, ISO62366, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive.
- 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)
- Experienced in and familiar with Human Factors Engineering - Usability Engineering and associated global regulatory requirements and standards.
- 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 Risk Management and Design Controls for Combinations Products
- Understand statistical sampling plan and statistical analysis of test results.
- 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.
Work Location Assignment: FlexiblePfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Research and Development