Manufacturing Process Engineer

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

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 rotating shifts as determined by the manufacturing processes and schedules.

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.

How You Will Achieve It

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

1. Primary point of contact for operator support and issue resolution as SME of process and equipment

• 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
• Uses scientific and OE tools/techniques to identify areas to optimize yield and/or and improve efficiencies
• Write and/or support formal manufacturing investigations

2. Ownership of Tech Transfer Deliverables

• Per guidance from sending site establish process parameters, timers, run rates, material flow, etc. and author tech transfer documentation
• 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
• 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

3. Supports Continuous Improvement Initiatives to Ensure Robust Manufacturing Processes

• Works with site Engineering, Automation, QA, etc.
• Determine/understand area/equipment interlocks
• Establish equipment synchronization requirements
• Participate in process operational improvements
• Conduct formal written risk assessment
• Review and revise cGMP documents
• Participate and lead change controls

Basic Qualifications

• BS degree in Life Science (e.g. Biology or Chemistry) or Engineering with 3 or more years of manufacturing experience in a FDA regulated industry or MS with 2 or more years of manufacturing experience in a FDA regulated industry.

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 a 24/7 manufacturing operation.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

24/7 (12 hours) and 24/5 (8 hours) rotating shifts

0-15% travel potential.

Other Job Details

• Last Date to Apply for Job: June 5th, 2022
• Eligible for Relocation Package: Yes

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.

Manufacturing

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