Lead Process Engineer

ROLE SUMMARY

The Lead Process Engineer is expected to serve as SME for core operational areas related to TS/Aseptic formulation and filling operations for a dynamic, 24/7 manufacturing operations. Key equipment will include formulation tanks, CIP/SIP skids, commodity washers, liquid filling, capping equipment, RABS/Isolators and sterilizers. Identifies, supports and/or manages projects executed by multiple functions including planning and scheduling all activities to achieve the desired results. Develops and manages project scopes for contractors and consultants in the support of project and process implementation. Leads in the development of project schedules and coordinate applicable work to meet the deadlines in the Plant Capital Plan, New Product Introductions, and New Process Technology Developments. Ensures all project documentation is generated per the schedule, executed on time and that it is complete and accurate. Leads the development of new processes and optimization of existing ones. Supports Data Integrity (DI) initiatives and maintenance of DI compliance associated with manufacturing processes and controls.

ROLE RESPONSIBILITIES

• Acts as the SME for critical process operations within TS/Aseptic formulation and filling operations. S/he is expected to have strong process/mechanical/controls knowledge of key process equipment to include formulation systems, CIP/SIP skids, commodity washers, liquid filling, capping equipment/vision systems, RABS/Isolators, and/or sterilization processes. Individual must have project management skills, knowledge and application experience of technical design reviews, commissioning and validation for pharmaceutical processes. Individual will be expected to work routinely with cross functional groups throughout the site for process improvements and implementation. S/he must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. Person will be responsible for interfacing with auditors and presenting on site processes.
• Responsible for leading and/or supporting root cause analysis and developing engineering resolutions for corrective actions. Troubleshoots production related equipment/process issues. Organizes, oversees and analyzes testing associated with the development of new process technologies and the support of new product introductions and tech transfers. Works closely with Corporate R&D and technical services to develop and confirm Critical and Key Process Parameters equipment and processes to ensure acceptable quality. Plans, reviews and approves engineering studies for engineering cycle development and research. Leads FAT (factory acceptance testing) and ensures protocol execution is per plan. Supports installation, operational, and performance qualification activities. Will direct the work of other process engineers and contract engineering resources, to include performance evaluations for Pfizer direct reports. Will be expected to establish methods for ongoing monitoring/trending of process/mechanical issues. Will be responsible for review and approval of site documents to include calibration reports, batch records, SOP's, change control, and design specs.

BASIC QUALIFICATIONS

• Bachelor's Degree in Engineering or Technical Science with 5+ years of pharmaceutical manufacturing engineering experience, to include hands-on technical application/knowledge of manufacturing equipment/processes required
  OR
• Master's Degree in Engineering or Technical Science with 3+ years of pharmaceutical manufacturing engineering experience, to include hands-on technical application/knowledge of manufacturing equipment/processes required
• Knowledge/understanding of global regulations for drugs
• Knowledge/understanding of CQV strategies
• Understanding of mechanical design, electro mechanical, and automation controls
• Excellent communication and presentation skills and attention to details
• Strong technical writing and presentation skills

PHYSICAL/MENTAL REQUIREMENTS

• Able to stand for extended hours for test runs and performance monitoring of processes - will include working within special gowning for cleanroom access
• Able to climb ladders/steps
• Able to lift items of 25lbs
• Capable of data analysis using statistical tools/graphing
• Strategic thinker for issue resolution

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Pfizer operates 24/7 across most of the business units. Employee must have the ability to work extended hours, holidays and/or weekends as needed. Limited travel may be required to support OEM equipment design reviews and/or Factory Acceptance Testing of new equipment. Employee will be expected to routinely work within clean room areas requiring special gowning to include full coverage gowning for Aseptic environments.

OTHER INFORMATION

• Last date to apply: 8/10/21
• Eligible for Relocation Package

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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