Sr. Manufacturing Process Engineer

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.

The incumbent will be knowledgeable of process equipment and systems, manufacturing operations, and 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 Manufacturing Area Leads.  The incumbent will provide technical guidance and systems and automation training to production colleagues. The position of Manufacturing Process Engineer requires direct production support on second shift (6 am – 6pm) as determined by the manufacturing processes.

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

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.

What You Will Achieve

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 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.

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 general 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

• SME of process, equipment, and automation change requests for prioritization

• Works with PCS to develop detailed automation design(s) and specifications

• Coordinates activities necessary to test and qualify equipment and automation changes in the production environment

• Uses scientific and OE tools/techniques to identify areas to optimize yield and/or and improve efficiencies

• Works with Tech Services, Engineering, Automation, QA, etc to ensure robust manufacturing processes:

• Contribute to P&IDs, PFDs and process descriptions

• Translate process descriptions instructions to meet production equipment / system capabilities

• Review and contribute to applicable documentation (i.e.  MBRs, SOPs, etc)

• Ensure equipment requirements can meet processing needs

• Review P&IDs and provide support as needed

• Per guidance from Tech Services establish process parameters, timers, run rates, material flow, etc as needed

• Determine area/equipment interlocks

• Establish equipment synchronization requirements

• Participates in process operational improvements

BASIC QUALIFICATIONS

• BS degree in Life Science (e.g. Biology or Chemistry) or Engineering with 7+ years of manufacturing experience in a FDA regulated industry or MS with four to 6+ years of manufacturing experience in a FDA regulated industry.

PREFERRED QUALIFICATIONS

• Working knowledge of vaccine or biotechnology product manufacturing in a cGMP environment, including a working knowledge of microbial fermentation and/or purification, Ultrafiltration /diafiltration, aseptic techniques and filtration processes.

PHYSICAL/MENTAL REQUIREMENTS

Capable of sitting and/or standing for extended periods of time during the work shift.  Must be able to work a rotating shift schedule to support 24/7 operation environment (6 AM – 6 PM).

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The position will be working on 3-2-2 work schedule requiring weekend coverage.

Other Job Details:

• Last Date to Apply for Job: December 6th, 2021

• NOT Eligible for Relocation Package

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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