Lead Aseptic Process Engineer

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.

Working with Pfizer’s dynamic engineering team, you will play a critical role in developing and modifying process formulations, methods and controls to meet quality standards. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review product requirements in terms of product development compatibility and help Pfizer determine optimum costs and schedules of production.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

This is a technical position and the primary function of this position is to support the sterile manufacturing areas in R1, R2 and R3. The Lead Aseptic Process Engineer would be accountable for the planning, execution, tracking, and completion of key manufacturing projects such as but not limited to: PQS implementation, shut down/restart process, media fill oversight and program management, investigation and change management. This candidate will also be accountable for implementing any new Annex 1 requirements impacting the Environmental Control department. This candidate must be able to work cross functionally with Operations, Maintenance, Validation, Process Engineering and MQ to deliver key milestones for projects. In addition, be accountable for troubleshooting activities necessary to return the areas back to a state of control and media fill investigations.

The candidate will be responsible for 2-4 aseptic process engineers

• Be accountable to work cross functionally and with direct reports to develop necessary tasks and project plan with proper scoping and duration for projects assigned.
• Support department leader and functional groups to ensure sterile manufacturing activities are properly assessed and ‘derisking’ plans are developed and executed within agreed timeline
• Work with department leader to ensure projects within the group are properly prioritized relative to other activities within the department
• Be accountable for the media fill program to ensure regulatory compliance of the program or be responsible to provide support to the media fill program
• Worked cross functionally with other departments to ensure media fills for the site are properly scheduled to minimized conflicts
• Conducts and writes formal investigation reports with the assistance from other departments, this includes interaction with corporate SMEs.
• Work with direct reports to performs impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.
• Implement, track, and close, Environmental Control department
• Utilize change management systems to update documents and procedures
• Perform necessary assessments of sterile operation and update necessary documents
• Assist in managing investigation workload for the department to ensure investigations/ CAPA’s are completed within the assigned time frame
• Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing
• Develop and coach direct reports on sterile manufacturing practices and ensure projects are properly scoped and prioritize for the group

• Requires Bachelor’s Degree in a technical field, such as Engineering, biology, etc, with 5+ year experience in a pharmaceutical manufacturing environment.
• 1+ year of supervisory experience in a pharmaceutical environment
• Must have demonstrated experience in Aseptic Processing.
• Must have comprehensive knowledge of media fills and how it applies to sterile manufacturing
• Requires thorough knowledgeof GMP’s and understanding in aseptic processing
• Must have the ability to handle multiple projects in a dynamic environment
• Must be self-directed and requires an appropriate level of experience to make and act upon decisions that impact the site from a sterile manufacturing standpoint
• Working knowledge of FDA regulations and Annex 1 requirements
• Knowledge of various quality tools, specifically around investigations and trouble shooting
• Prior investigation writing experience (with determination of product impact)
• Excellent facilitation skills and ability to facilitate strategy meetings
• Superior technical writing and problem-solving skills
• Organize data, extract key information and write technical summary reports
• Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis
• Must be able to work on weekend, off shifts and holiday as business demands
• Must be able to work in a team setting and willing to lead others

• Master's degree
• Relevant pharmaceutical experience

PHYSICAL/MENTAL REQUIREMENTS

Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.

Must be able to aseptically gown.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be able to work on weekend, off shifts and holiday as business demands

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.

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.