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.
Provide engineering and technical subject matter expertise related to the evaluation, technology transfer, startup, and qualification of new and existing equipment, facilities, and utilities in support of new product introduction. This may include production equipment such as bioreactors, ultrafiltration skids, Clean – In – Place (CIP) skids, chromatography skids, and other support equipment.
Responsible for the introduction of new products into an existing biopharmaceutical facility
Perform new product facility fit assessments including equipment selection and sizing and utility usage estimates
Develop tech transfer and product changeover scopes of work and work with planners and schedulers to plan and implement the work
Execute the design, commissioning, and qualification of improvements, changes, or upgrades to this equipment as needed
Develop validation and qualification plans, protocols, and summary reports
Perform component, equipment, and process improvement projects as needed
Participate in implementation of PLC, HMI, and database configuration changes
Engage with vendors/manufacturers to procure equipment, components, and manufacturing instruments
Perform planning and scheduling through development of process models using Schedule Pro
Identify and implement improvements to reduce product changeover time in the suite
Identify and support long term capital projects to improve new product introduction efficiency
Provide on the floor operational support as needed
Provide off-shift and on call support when necessary
Apply technical expertise in Operations, Quality, and Validation to recommend improvements considering business challenges.
Lead cross-functional project teams through high-risk technical assessments and develop complex engineering solutions.
Provide guidance and lead moderately complex projects, managing time and resources effectively.
Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems.
Work independently, review own work, mentor colleagues, and exercise judgment utilizing knowledge and experience.
Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of
relevant experience
Relevant experience in biopharmaceutical industry
Knowledge of Good Manufacturing Practices and experience in Pharmaceutical environment
Candidate must be able to work across functional areas such as operations, technical services, maintenance, quality and regulatory
Knowledge working with computers and associated applications such as MS Word, Excel, and PowerPoint
Broad knowledge of theory and principles within the engineering discipline
Strong technical, management and organizational skills
Good leadership and communication skills
Ability to solve complex problems
Ability to locate information and utilize available organizational knowledge to develop innovative solutions
Strong technical writing skills
Strong history of problem-solving skills, project and task management skills
Ability to manage priorities and lead others under pressure
Knowledge of database applications and Delta V, Allen-Bradley PLC, GE iFix and iHistorian
Experience authoring, reviewing, and approving User Requirement Specifications, Functional Specifications, and Configuration Specifications
Knowledge of the manufacturing process and equipment, preferably bacterial fermentation and purification processes
Experience Commissioning, Validating, and Qualifying new or existing equipment
Experience with GMP Change Management
Proven ability to work collaboratively in a cross-functional team environment
Strategic planning and forecasting skills
Ability to facilitate agreements between various teams
Experience using common AItools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
PHYSICAL/MENTAL REQUIREMENTS
Ability to sit, stand, bend, and walk to access equipment in a clean room environment
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Minimal travel for equipment support
Ability to work off shift (Nights and Weekends) as needed
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.