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Senior Process Engineer

Company: Pfizer
Location: Rocky Mount
Posted on: November 7, 2019

Job Description:

ROLE SUMMARY The Sr. Process Engineer is expected to serve as an SME for core operational areas related to finishing and packaging operations for a dynamic, 24/7 manufacturing operations. Key equipment will include Labelers, cartoners, bundlers, vision systems, automated visual inspection, leak detection and serialization equipment for processing of small volume parenterals. Identifies, supports projects executed by multiple functions including planning and scheduling all activities to achieve the desired results. Supports development and management of project scopes for contractors and consultants in the support of project and process implementation. S/he supports the development of project schedules and coordinates 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. S/he leads the development of new processes and optimization of existing ones. ROLE RESPONSIBILITIES - Acts as the SME for critical process operations within finishing operations. Expected to have strong process/mechanical/controls knowledge of key process equipment to include labelers, cartoners, bundlers, vision systems, automated visual inspection, leak detection and serialization equipment. - 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. - Must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to process improvements and changes. 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. - 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 an Engineering field or similar discipline with a minimum of 3 years of relevant experience is required, or a Master's Degree in an Engineering field or similar discipline with 1 year of relevant experience is required. - Knowledge/understanding of commissioning and qualification strategies - Excellent communication and presentation skills and attention to detail - Strong technical writing and presentation skills PREFERRED QUALIFICATIONS - 3 years of pharmaceutical industry experience is preferred - Knowledge/understanding of global regulations for drugs - Understanding of mechanical design, electro mechanical, and automation controls - Experience with serialization is preferred PHYSICAL/MENTAL REQUIREMENTS - Able to stand for extended hours for test runs and performance monitoring of processes - will include working within special gowning for area 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. 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. OTHER JOB DETAILS - Last Date to Apply for Job: 10/24/19 - Eligible for Relocation Package - Eligible for Employee Referral Bonus - #LI-PFE Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Keywords: Pfizer, Rocky Mount , Senior Process Engineer, Engineering , Rocky Mount, North Carolina

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