Use Your Power for Purpose
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring that customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you will contribute to delivering medicines to the world at an accelerated pace by envisioning new possibilities and taking decisive action. Your role in the design and development of manufacturing processes, as well as in maintenance and reliability support, is essential for providing timely access to necessary medications. Working alongside our innovative team, you will help expedite the delivery of medicines globally by imagining what can be achieved and making it happen.
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
The Senior Associate Manufacturing Engineer supports the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule for mAb products. The Senior Associate Manufacturing Engineer will participate and lead interdisciplinary and cross functional teams, to own and implement process improvements, and lead/participate in process troubleshooting.
How You Will Achieve It
Supports manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
Point of Contact for the execution and issue resolution associated with process equipment commissioning, qualification and validation.
Owns troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
Delivers Right first time execution and continuous improvement; Monitor, Identify and/or Communicate process and compliance trends in real time.
Participate in the authoring role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
Responsible for remaining current on assigned training.
Leads Lean Manufacturing, Sustainability and Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
Leads in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
Generates work requests when issues arise with facility / manufacturing equipment. Provides support to maintenance to facilitate resolution, when needed. Point of contact for emergency work orders.
Skilled in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
Identifies the need for escalation through various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.
Lead cross-functional project teams through high-risk technical assessments and develop complex engineering solutions.
Leads and coaches beginner Manufacturing Engineers through complex troubleshooting, investigations, and projects
Oversee and conduct supplier technical audits and corporate audits.
Actively share knowledge within the team through established systems.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 2 years of experience; or a master's degree with more than 0 years of experience; or an associate's degree with 6 years of experience or a high school diploma or equivalent with 8 years of relevant experience.
Demonstrated knowledge of Good Manufacturing Practices and experience in a pharmaceutical environment.
Proficiency in project-oriented admin, cost control, and management
Strong technical management and organizational skills
Good leadership and communication abilities
Bonus Points If You Have (Preferred Requirements)
Experience in automation including DeltaV and equipment validation
Knowledge of the manufacturing process and equipment, preferably bacterial fermentation and purification processes
Strong problem-solving skills
Experience in facilitating project meetings and managing project finances
Commitment to safety and compliance with biosafety requirements
PHYSICAL/MENTAL REQUIREMENTS
Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
This role is fixed Days 2/2/3 twelve-hour shifts to support execution of mAb manufacturing.
Limited Travel 10%.
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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.
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