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 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 play a key role in accelerating the delivery of medicines to the world. Your innovative ideas and proactive actions will help us imagine new possibilities and bring them to life, ensuring that our solutions are both timely and effective. Your contributions will be essential in ensuring that our manufacturing processes are efficient, reliable, and of the highest quality, ultimately helping us deliver life-saving medicines to those who need them most.
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 Associate Process Engineer supports the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule for mAb products . The Associate Process Engineer will work on 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.
Here Is What You Need (Minimum Requirements)
Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding
Working knowledge of Food and Drug Administration Regulations and Good Manufacturing Practices
Proactive, with experience in high-performance teams, strong interpersonal and project management skills
Strong written and verbal communication skills
Proficiency in Microsoft Applications
Ability to work effectively in a team environment and collaborate with cross-functional teams
Bonus Points If You Have (Preferred Requirements)
Demonstrated experience in a relevant manufacturing environment
Knowledge and experience with Drug Substance processing and equipment
Experience with process validation and equipment qualification
Familiarity with Lean Manufacturing principles and Six Sigma methodologies
Excellent organizational skills and attention to detail
Strong leadership and mentoring abilities
Ability to adapt to changing priorities and work effectively under pressure
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
The annual base salary for this position ranges from $66 500,00 to $110 900,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7,5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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.
Engineering
LI-PFE
