Principal Process Engineer, GTx Manufacturing

Pfizer, Inc.

Sanford, NC

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 Gene Therapy Operations 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 Downstream Principal Process Engineer, your planning skills will help 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 the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a cross functional leadership role to facilitate agreements between different team.

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 technical support as primary point of contact for Manufacturing
  • Support of process and component improvements projects as needed.
  • Evaluate, manage, and report the process capability of the equipment and services employed in the operation.
  • Manage supplier technical audits and Pfizer corporate audits.
  • Actively coach and mentor others within the team through existing knowledge sharing processes and systems.
  • Apply technical knowledge of Operations, Quality, Validation, etc. along with internal/external business challenges to provide input into recommendations for improvements.
  • Lead multi-functional project teams through high technical risk assessments and complex engineering/technology solution development.
  • Proactively identify areas for improved efficiencies and ensure that product quality is maintained through all phases of production including operational parameters of manufacturing equipment, automation control, processing dynamics, and integrated utilities to identify and resolve quality, and technical, risk to manufacturing. Serve as the areas technical SME and develops expertise in various manufacturing operations and processes including automation controls that operate and monitor the processes.

  • Requires in-depth knowledge of scientific principles, technical knowledge of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on assigned production area.

  • Capable of identifying technical problems and solving them with minimal guidance. Ability to analyze operational process issues and automation challenges to recommend / initiate appropriate corrective and preventative actions. Acts as a departmental liaison with primary support groups such as engineering, technical services, quality control, quality assurance, development and utilities. The incumbent will manage / implement process, equipment, and automation changes in support of manufacturing operations.

    Key responsibilities

  • Responsible for problem diagnosis / root cause(s) determination (automation, mechanical, documentation, training, etc)

  • Coordinate activities with PCS to resolve automation issues and changes

  • Coordinate activities with maintenance to resolve mechanical issues

  • Supporting and author manufacturing investigations to support deviations

  • Work to develop and actively contribute to GTx process monitoring and verification activities, including benchmarking and monitor process performance using statistical tools

  • Partner with current team to ensure consistency between unit operations

  • Designs technical and engineering studies, writes technical reports summarizing study results, and generates necessary data to support change impact assessments during process transfers and investigations.

  • Authors process and equipment descriptions, process flow diagrams and risks assessments.

  • Initiate and supports change management and implementation for changes to the manufacturing processes and associated systems. Own change controls related to process changes.

  • Identifies potential process improvements projects. Leads and supports implementation of process improvements projects and supports compliance driven projects that require technical support.

  • Author and contribute to the development and modifications of operational process and equipment documentation including SOP , Job aid and Master batch records.

  • Authors process descriptions, process flow diagrams and risks assessments.

  • Supports process transfers to the Sanford Gene Therapy facility

  • Supports continuous process verification program

  • Independently learn new systems and software needed for process monitoring and lead implementation of such

  • Recommend new approaches for data monitoring based on subject matter expertise

  • Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an Associate's degree with 8 years of experience OR a Bachelors with at least 5 years of experience OR Master's Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
  • In-depth knowledge of cGMP (current Good Manufacturing Practices).

  • Strong history of problem-solving skills, project and task management skills, ability to manage priorities and lead others under pressure.

  • Strong verbal and written presentation communication skills and attention to detail.

  • 5+ years of experience in product development, manufacturing science and technology, process validation, or Process Engineering within the pharmaceutical industry
  • Degree in Bioprocessing, Engineering, Biology, Chemistry or related discipline
  • Manufacturing experience with single use bioprocessing technologies,
  • Experience with AAV and/or protein purification unit operations strongly preferred
  • Previous process transfer experience

Physical/Mental Requirements:

  • Capable of sitting and/or standing for extended periods of time during the work shift, lifting up to 40lbs .
  • Remains organized &; positive in ambiguous and fast-paced, rapidly changing environment
  • Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure and in ambiguous situations
  • Ability to process complex information and make recommendations with incomplete data set

Non-Standard Work Schedule, Travel, or Environment Requirements:

  • This role is standard day Monday through Friday work shift. Ability to adjust work schedule to meet business needs – overtime, off shift, weekends.
  • Ability to travel– travel time may be up to 20% according to business needs.

Other Job Details:

  • Last day to Apply: August 15th, 2023
  • Eligible for Relocation Assistance: Yes
  • Work Location Assignment: On Premise

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.

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