Senior Process Engineer
Job Description
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 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.
What You Will Achieve
Working with Pfizer’s dynamic engineering team, you will play a critical role in the design and development of manufacturing processes to bring products from research to manufacturing. You will leverage your technical capabilities to understand the inherent problems of transfer of technology from the research stage to manufacturing, in cooperation with pilot-plant and production departments. You will conduct tests and measurements throughout the stages of production and troubleshoot production process problems with processes or equipment already in operation.
As Senior Process Engineer, you will play a vital role in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of engineering, you will also work towards advancing new concepts and methodologies.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the department.
- The incumbent will be the leading technical representative/coordinator from the Tech Services/Biotech Operations organization for the cGMP Manufacturing areas.
- Collaborate to identify and implement improvements in the business practices across Pfizer Global Supply, and Research and Development.
- Drive alignment across stakeholders on technical strategies and priorities identified in technology lifecycle plan.
- Provide technical support the manufacturing operations processes and support regulatory affairs for new drug filing, and audit support.
- Responsible for project budgets and reporting to Program Team, Asset Team and associated Business Unit.
- Provide technical leadership for biological, vaccine, large molecule projects.
- Measure the output of risk assessment and initiatives executed with each site to ensure optimal process robustness and knowledge management results are obtained.
- Represent validation program during audits and inspections, support the instrument validation program and procedural changes that enhance safety, compliance, and operational efficiency.
- Develop solutions to complex problems which requires the use of ingenuity, innovation, and creativity.
- Manage, implement and monitor instrument validation activities.
- Identify issues related to new products requiring decisions and/or actions by management.
- Lead Product Technology Team, cross functional team across all manufacturing sites , operations, technology groups and enabling groups.
Qualifications
Must-Have
- Applicant must have a High School Diploma (or Equivalent) with 10 years of relevant experience; OR an Associate's degree with eight years of experience; OR a Bachelor’s degree with at least five years of experience; OR a Master’s degree with more than three years of experience; OR a Ph.D. with 0-2 years of experience.
- Practical experience in facilitating and conducting risk assessments.
- Strong mammalian cell culture expertise required, knowledge of other heterologous expression systems.
- Demonstrated ability to provide technical leadership for biological, vaccine, large molecule projects.
- Ability to identify and implement improvements in the business practices across Pfizer Global Supply, and Research and Development.
- Track record of success in developing solutions to complex problems requiring the use of ingenuity, innovation, and creativity.
- Ability to manage, implement and monitor instrument validation activities, and track record of representing validation program during audits.
Nice to Have
- Experience with manufacturing of monoclonal antibody API materials for clinical (including late stage clinical) and commercial phases.
PHYSICAL/MENTAL REQUIREMENTS
- Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
- Must have the ability to lift ~50 pounds.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- . Manufacturing is conducted on a 24 hour/7 day a week operation, and this role and team are expected to provide support accordingly.
Relocation support available
Last Date to Apply: April 8, 2024
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.
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.
