Sr Production Engineer (Carpuject Focus Factor Packaging), McPherson, Kansas

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.

Role Summary (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. The role will specifically support the Fill Team and Central Dispensing 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 as determined by the manufacturing processes and schedules.

Role Responsibilities (HOW YOU WILL ACHIEVE IT)

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.

The role is to provide senior level engineering business partnership to the packaging and manufacturing operations leaders. The role will partner with operations, engineering, maintenance and reliability teams to drive overall Equipment and Process improvement and key strategic projects. The role must demonstrate ability to accomplish large and complex projects independently, provide engineering expertise and lead structured troubleshooting efforts of major equipment and process-related issues. Analyzes process requirements and evaluates equipment and systems to ensure deliverables meet or exceed process specifications and packaging/manufacturing requirements. Evaluates and recommends new process technologies that optimize performance, are cost effective, and will improve product quality and manufacturing processes.

Spends 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. Role will also support batch record and SOP revisions, commitment ownership, project management and investigations as needed.

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

Supports the production area throughput and efficiency by driving large scale projects and improvement programs. Will lead transformational change projects that cross functions and production lines.

Evaluate/monitor and identify downtime and root cause, Change Over and cleaning activities to meet the standard time.

Leads teams of engineers and professionals to ensure improvement ideas are implemented and track progress on confidence curve.

Triage and lead RCA for equipment downtime and process failures on the shop floor.

Manage large and complex engineering projects in operations to include process and equipment redesign and new system implementation.

Drive and support Reliability improvement initiatives and lead TPM implementation. Will supervise Process Technologist roles.

Generate required documentation (Change Requests, Commissioning protocols, Plant Trial protocols, Work Orders) to implement process related actions as required.

BASIC QUALIFICATIONS

BS in Engineering discipline (Mechanical, Electrical, Industrial, Chemical Engineering).

5+ years of experience in GMP Manufacturing.

Demonstrated ability to successfully lead and manage complex/large engineering projects.

Demonstrated leadership experience.

Demonstrated ability to lead technical shop-floor troubleshooting and problem solving.

Position requires technical, safety and cGMP training.

PREFERRED QUALIFICATIONS

MS in Engineering discipline.

2+ years of experience in an Aseptic Manufacturing industry.

Experience directly leading the implementation of Continuous Improvement projects, Operational Excellence and TPM.

Other Job Details:

Last day to apply to job: 20 APRIL 2021

Eligible for Relocation

Eligible for Referral Bonus

PHYSICAL/MENTAL REQUIREMENTS

Role requires significant time standing in the shop floor and ability to dress in pharmaceutical PPE.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Weekend and holiday work may be required, if needed. Ability to operate in a classified area.

Role supports a 24/7 operation. Must be available to provide on-call support during weekends, holidays and after working hours.

Role requires significant time standing in the shop floor and ability to dress in pharmaceutical PPE.

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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