Senior Associate Process Engineer, Gene Therapy Manufacturing

Role Summary

As a member of the gene therapy Operations team located in Sanford, NC, the Process Engineer will play a pivotal role in the start-up and ongoing operations to support the gene therapy production facilities in Sanford, NC.  Scope of work will include process performance monitoring, support for change controls and deviations as well as identification and implementation of process improvements.

The incumbent will be knowledgeable of process equipment and systems, production operations, automation control (Delta V, etc) and provide direct production support during processing operations. Services include review of process requirements and evaluation of equipment and systems to ensure deliverables meet or exceed process specifications and manufacturing requirements.  The incumbent will assist with production planning and provide / support coordinating production activities working with the production area leads.  The incumbent will provide technical guidance and training on process equipment and automation systems to production colleagues. The position of Process Engineer requires direct production support.

The incumbent provides process engineering support of cGMP clinical and /or commercial manufacturing processes and equipment.  Analyzes repeated issues with equipment.   Provides process engineering support to ensure operational success of the maintenance coverage program.     

Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Pfizer Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.  Advise management of non-conformance issues and opportunities for continuous improvement via data trend analysis, interpretation of data, gap analysis and implementation of corrective activities.  Provides input on decisions for SOP’s, batch records, forms or other cGMP related documents developed or revised to support continuous improvement efforts, investigation corrective actions, process descriptions, manufacturing operations, automation control (DeltaV, etc.) and regulatory audit commitments.

Further responsibilities include supporting and formally writing manufacturing investigations to support deviations, reviewing and revising cGMP documents, conducting formal site risk assessments, and participation in site change control.

Role Responsibilities

• Spends majority of time on the production floor to 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

• Primary point of contact for operator support and issue resolution

• 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 facilities

• Authors and contributes to validation plans, protocols and reports

• 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

Qualifications

Required:

• BS or Masters in Engineering, Bioprocessing, Biology or related discipline is required. 

• MS with 1-3 years, BS with 3-5 years of relevant experience in GMP biopharmaceutical industry

• Driven to take ownership of equipment and technical issues.

• Keen attention to technical detail.

• Basic knowledge of DeltaV and PI systems Experience with authoring technical study protocols and reports

• Statistical knowledge to analyze process data and experience with statistical software used for process monitoring

• Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.

• Must be self-motivated and work with minimum direction

• Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.

• Ability to focus on specific production processes with great attention to details

Preferred

• Manufacturing experience with single use bioprocessing technologies.

• Experience in downstream biotechnology processes.

• 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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Remains organized and positive in 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.

Additional Information

• Last Date to Apply for Job: October 14th, 2021

• Referral Bonus Eligible

• Relocation Support Available

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.

Engineering

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