Sr. Manufacturing Process Equipment Engineer
- Employer
- Pfizer
- Location
- Sanford, North Carolina
- Start date
- Jul 30, 2021
View more
- Discipline
- Engineering, Manufacturing & Production, Manufacturing/Mechanical
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Bio NC, Best Places to Work
Why Patients Need You
The incumbent will be knowledgeable of process, equipment and systems, manufacturing operations, and preferably automation control (Delta V, etc).
The incumbent will provide direct day-to-day support for equipment related issues that occur during the processing operations.
The incumbent would be responsible for front line troubleshooting of mechanical, electrical but not automation issues, when it is deemed to be too complex for manufacturing colleagues, including manufacturing Process Engineers (PEs) to first address.
The engineer in this role is second line of defense for on-floor troubleshooting.
The incumbent will work with area PE’s and Supervisors to provide / support coordinating maintenance/PM activities.
The incumbent will support Total Productive Maintenance implementation with focus on operator care, work management, reliability-based maintenance, process engineering support of cGMP 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. Incumbent works with colleagues and PE’s to increase skills to perform front line troubleshooting.
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
The incumbent will be accountable that all equipment is safe, effective and in compliance with industry standards, all company and site engineering policies and procedures. Engineer will provide technical and compliance review of testing protocols, reports and applicable manufacturing SOPs. Spends majority of the time troubleshooting mechanical and electrical related issues in the production facility to ensure smooth batch production and maintain RFT culture in production areas to identify and resolve quality, and technical, risk to manufacturing. Provide technical training on process and equipment as required by Operations. Develop and maintain productive links with process equipment & technology supplier and vendors.
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 equipment changes in support of manufacturing operations.
Will be integral team member of Total Productive Maintenance and implementation of various aspects of the program such as equipment care, etc. Coordinate and escort outside equipment maintenance contractors. Identify equipment improvement and develop these into project scopes for Core Engineering/ Technical Services, this may also include progressing to funding approvals, supporting Change Controls for equipment. Provide technical expertise during audits and also to present/ defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies if required. Lead/ represent Equipment engineering on short duration project teams where responsibilities would include SME technical oversight and the management and resolution of technical issues or changes arising throughout the project lifecycle whilst ensuring overall project objectives of scope, cost and schedule are adhered to.
Support investigations into equipment and/or process failures and implement equipment CAPA and performance improvements. Support cGMP validation, review documents for requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, risk assessments, protocols and reports to maintain the equipment in a validated state.
Work to implement a culture of Right-First Time through partnerships with Operations and Core Engineering and Core Technical Services
Key Responsibilities
Mechanical Troubleshooting
Electrical Troubleshooting
Responsible for problem diagnosis / root cause(s) determination (mechanical, electrical) documentation, training, etc)
Coordinate outside equipment maint. Contractors
SME rep to capital project team meetings (culture shift)
Validation - revalidation docs and execution
Investigations - Equipment
Utility Points of Use are owned by area
Upskilling ops techs on asset care daily coaching
Identify and order items for manufacturing. (hoses and other items that should be standardized across the site and not taken casually)
Participates in area walkthroughs in support of audits and start up preparation. Writes all work orders required to pass audit.
Identify, and implement improvements to, recurring equipment inefficiencies that do not necessitate event reports (communication with reliability engineering where appropriate)
Own the document periodic review process with respect to equipment
Provide coaching to RFT specialists on equipment nuances
Performs periodic reviews of asset care strategy to ensure its content is current with equipment owners
SME of process, equipment, and automation change requests for prioritization
Uses scientific and OE tools/techniques to identify areas to optimize yield and/or and improve efficiencies
o Translate process descriptions instructions to meet production equipment / system capabilities
o Review and contribute to applicable documentation (i.e. MBRs, SOPs, etc)
o Ensure equipment requirements can meet processing needs
o Review P&IDs and provide support as needed
o Determine area/equipment interlocks
o Establish equipment synchronization requirements
o Participates in process operational improvements
Qualifications
Must-Have
EDUCATION AND EXPERIENCE
BS degree in Life Science (e.g. Biology or Chemistry) or Engineering with minimum 7-10 years of cGMP industrial experience, ideally covering Operations, Engineering, Projects and equipment qualification within bioprocess manufacturing. In depth understanding of equipment engineering for all unit operations and fundamental understanding of potential impact of equipment on product. Working knowledge of production operations, scheduling, design, planning, process evaluation, equipment selections calculations etc.
Nice-to-Have
Working knowledge of vaccine or biotechnology product manufacturing in a cGMP environment, including a working knowledge of microbial fermentation, Ultrafiltration /diafiltration, aseptic techniques and filtration processes. Ability to upgrade or direct technical aspects of equipment installation, start-up, troubleshooting and repair or to obtain appropriate outside repair services to accomplish same. Experience working with automated control systems. Experience of FDA and EU licensing and inspection. Excellent communication and interpersonal skills and an ability to work independently. Experience of equipment qualification and requalification
PHYSICAL/MENTAL REQUIREMENTS
Capable of sitting and/or standing for extended periods of time during the work shift.
Primarily this position is a day shift but must be able to work in shift schedule to support 24/7 manufacturing operation.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Primarily day shift but may be required to work at odd hours to support 24/7 manufacturing operations.
Ability to operate in a classified area.
Other Job Details:
Last Date to Apply for Job: August 13th, 2021
- NOT Eligible for Relocation Package
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