ROLE SUMMARY
This position is for a Subject Matter Expert (SME) for Lyophilization (also referred to as Freeze Dry or Lyo) operations. The scope of the role includes support of Lyophilization related capital projects and operational support of existing Lyophilization operations.
Key accountabilities include ensuring that the existing lyophilizers are functioning at an optimal state and that all new lyophilizers or modified lyophilizers function as intended to successfully manufacture drug products on schedule, ensuring all product is produced in a manner meeting safety and quality requirements.
ROLE RESPONSIBILITIES
Serves as subject matter expert on lyophilizer and/or automated loading/unloading systems.
Serves as responsible person for functionality of the lyophilization equipment, interfaces closely with operators, freeze dry leadership, maintenance, automation, and quality to ensure the lyophilizers are functioning as intended.
Identifies and implements technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.
Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.
Identifies and implements safety improvement ideas and projects.
Investigates deviations that arise during lyo cycles. Performs root-cause analysis and identifies appropriate, effective corrective actions.
Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety.
Able to review lyo data trends to determine level of functionality of the equipment and processes to ensure all validated criteria are met and equipment is performing at optimal levels.
BASIC QUALIFICATIONS
Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
Effective verbal and written communication skills
Proficiency in MS Office programs
Strong organizational skills
Basic understanding of manufacturing processes
Pharmaceutical or manufacturing experience and strong, demonstrated project management skills exhibited in a cGMP environment are requirements.
Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.
Successful candidate must be familiar with tools and techniques required to manage large scale complex projects through multi-disciplinary teams.
PREFERRED QUALIFICATIONS
Pharmaceutical experience in Operations Engineering
Experience in a highly regulated environment
Knowledge of cGMP and regulatory standards
Strong problem-solving skills
Ability to identify and implement cost-effective solutions
Experience in optimizing production workflows
Manufacturing experience with lyophilization equipment or unit operations common to lyophilization (wet/dry vacuum pumps, mechanical cooling, liquid nitrogen cooling, heat exchangers, and process control systems)
PHYSICAL/MENTAL REQUIREMENTS
Aseptic Gowning to access production floor will be required.
Ability to troubleshoot complex automated systems is required.
Strong aptitude for learning process technology and equipment
Job will include standing, walking, and sitting.
Occasional lifting may be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel may be required for specific projects, training, or network support. (≤5%)
Job may also require occasional weekend/evening work supporting a 24-hour/7-day operation.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
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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. This position requires permanent work authorization in the United States.
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