12 Aug, 2021

Senior Process Engineer

  • Pfizer
  • Rocky Mount, NC, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

    • United States - North Carolina - Rocky Mount
  • ROLE SUMMARY

    The Sr. Process Engineer is primarily responsible for executing projects planned by Process Engineering. This individual ensures all Process Engineering documentation deliverables are generated, and may be asked to develop new processes or optimize existing ones. This individual may lead large scale projects; as well as, coordinate all work including but not limited to coordination of personnel activities, documentation and outside resources. The Sr. Process Engineer will develop and manage project scopes for contractors and consultants in the support of project and process implementation.

     

    The Sr. Process Engineer supports manufacturing processes and operations at the Rocky Mount, NC facility. Work includes but is not limited to supporting identification and implementation of process improvements, system design, capital project support, and investigation support. Individual ensures all Process Engineering documentation deliverables are generated, is expected to develop new processes and/or optimize existing ones. This individual may lead large scale projects; as well as, coordinate all work including but not limited to coordination of personnel activities, documentation and outside resources. The Sr. Process Engineer will be required to develop and manage project scopes for contractors and consultants in the support of project and process implementation. 

     

    The Sr. Process Engineer is expected to support a broad range of equipment and processes. Employee will be working within a sterile injectable facility, which may include working within clean rooms. Equipment and processes may include packaging/automated visual inspection processes, Formulation systems, CIP/SIP skids, commodity prep, washing, filling, capping and/or sterilization (to include dry heat ovens/tunnels and autoclaves) processes for a broad range of products and product configurations. Engineer will be expected to work with corresponding teams (automation, maintenance, ops, validation, quality functions) at the site to understand, implement and improve processes. Engineer is expected to understand the overall process sequences beyond individual equipment and impact on product quality.

     

    ROLE RESPONSIBILITIES

    • SME for critical process operations within formulation and filling operations.
    • Expected to have strong process/mechanical/controls knowledge of key process equipment to include commodity washers, depyrogenation tunnels, autoclaves, fillers, cappers, vision systems, CIP/SIP processes and formulation systems such as mixing tanks.
    • Individual must have project management skills, knowledge and application experience of technical design reviews, commissioning and validation for pharmaceutical processes.
    • Individual will be expected to work routinely with cross functional groups throughout the site for process improvements and implementation.
    • Must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. Responsible for interfacing with auditors and presenting on site processes.
    • Responsible for leading and/or supporting root cause analysis and developing engineering resolutions for corrective actions.
    • Troubleshoots production related equipment/process issues.
    • Organizes, oversees and analyzes testing associated with the development of new process technologies and the support of new product introductions and tech transfers.
    • Works closely with Corporate R&D and technical services to develop and confirm Critical and Key Process Parameters equipment and processes to ensure acceptable quality.
    • Plans, reviews and approves engineering studies for engineering cycle development and research. Leads FAT (factory acceptance testing) and ensures protocol execution is per plan.
    • Supports installation, operational, and performance qualification activities. Direct the work of other process engineers and contract engineering resources, to include performance evaluations for Pfizer direct reports.
    • Expected to establish methods for ongoing monitoring/trending of process/mechanical issues. Responsible for review and approval of site documents to include calibration reports, batch records, SOP’s, change control, and design specs.

     

    BASIC QUALIFICATIONS

    • Bachelor’s Degree in an Engineering or related discipline with a minimum of 3 years of engineering experience is required.
    • Understanding of mechanical design, electro mechanical, and automation controls is required.
    • Excellent communication and presentation skills and attention to details are required.
    • Strong technical writing and presentation skills are required.

     

    PREFERRED QUALIFICATIONS

    • Pharmaceutical industry and GMP experience is preferred.
    • Knowledge/understanding of global regulations for drugs is preferred.

     

    PHYSICAL/MENTAL REQUIREMENTS

    • Able to stand for extended hours for test runs and performance monitoring of processes – will include working within special gowning for area access
    • Able to climb ladders/steps
    • Able to lift items of 25lbs
    • Capable of data analysis using statistical tools/graphing
    • Strategic thinker for issue resolution

     

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

    Pfizer operates 24/7 across most of the business units. Employee must have the ability to work extended hours, holidays and/or weekends as needed. Limited travel may be required to support OEM equipment design reviews and/or Factory Acceptance Testing of new equipment.

     

    Other Job Details:

    • Last Date to Apply for Job: 8/16/21
    • Eligible for Relocation Package
    • Eligible for Employee Referral Bonus

     

     

    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.


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