Pfizer, S.A. de C.V
Associate Manufacturing Engineer
Pfizer, S.A. de C.V, Sanford, North Carolina, United States, 27330
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
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.
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 communicate process and compliance trends in real time.
Participates 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/machinery; provide 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.
Minimum Requirements
Applicant must have a bachelor's degree with 0+ years of experience; or an associate’s degree with 4 years of 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.
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.
Travel and Work Schedule
This role is fixed nights 2/2/3 twelve‑hour shifts (6PM - 6AM) 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.
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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To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
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.
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 communicate process and compliance trends in real time.
Participates 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/machinery; provide 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.
Minimum Requirements
Applicant must have a bachelor's degree with 0+ years of experience; or an associate’s degree with 4 years of 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.
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.
Travel and Work Schedule
This role is fixed nights 2/2/3 twelve‑hour shifts (6PM - 6AM) 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.
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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