Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
Provides technical expertise and operational support for Drug Product Operations and specifically the new Modular Aseptic Processing (MAP) facility. This position will support the capital project from an Operational Readiness standpoint in Formulation and Dispensing workstream. This will include partnering with OEM vendors, automation, engineering, verification and quality to ensure the facility meets operational, quality and EHS requirements. The position will transition to an operations support role after regulatory approval. Partners with shop floor colleagues and supervision to ensure smooth and efficient production of a diverse mix of products. Assists in equipment troubleshooting activities as needed. Serves as a subject matter expert within the site for highly automated aseptic formulation and dispensing systems. Responsible for technical development of junior colleagues.
How You Will Achieve It
Develop User Requirements for OEM equipment and highly automated systems.
Support capital project from an Operational Readiness standpoint to include: Verification and testing support, SOP development, training, IMEx deliverables.
Develops and validates manufacturing processes for drug products, taking into consideration problems inherent in the transfer of technology from research to production, from other sites, or within the site.
Collaborates with and influences other enabling departments (Quality, Engineering, Maintenance, etc.) to assure initiatives are successful.
Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.
Conducts tests and measurements throughout stages of production to determine control over applicable variables.
• Investigates deviations that occur on the manufacturing floor. Performs root-cause analysis and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety.
• Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.
• Provides concise and thorough updates on initiatives to site leadership.
• Mentor junior level colleagues inside and outside of department.
Must have HS Diploma with ten years of relevant experience; OR an Associate's degree with eight years of experience; OR a Bachelor’s degree with at least five years of experience; OR a Master’s degree with more than three years of experience; OR a Ph.D. with 0-2 years of experience
Thorough knowledge of cGMP (current Good Manufacturing Practices), combination device regulations, design control
Strong history of problem solving skills, project and task management skills, ability to manage priorities and lead others under pressure
Strong verbal and written presentation communication skills and attention to detail
Pharmaceutical or manufacturing experience and strong, demonstrated technical skills exhibited in a cGMP environment are requirements.
Specific knowledge of and experience with Drug Product processing and equipment in highly automated aseptic preparation, formulation, filling, isolator, or lyophilization systems is highly desirable.
Job will include standing, walking, and sitting. Occasional lifting may be required.
Aseptic gowning training may be required. Job may also require occasional weekend/evening work supporting a 24-hour/7-day operation.
Non-Standard Work Schedule, Travel, or Environment Requirements
Up to 25% domestic and/or international travel
Work Location Assignment:On Premise
Other Job Details
- Last Date to Apply: August 11, 2022
- Eligible for Relocation Package: YES
Pfizer 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.
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.