ROLE SUMMARY
Successful candidate will be in the sterilization technology group and be assigned a specific technology to learn and eventually oversee all sterilization systems on the site that use that technology. Candidate will be responsible for writing, executing with assistance, and then completing final report for each annual requalification of the individual systems that are under their responsibility.
Candidate will interact with other team members within the Microbiology Department and with team members from other departments, primarily within the Quality and Drug Product Operations organizations to ensure high-quality execution and completion of sterilization validation responsibilities. Will interface with many levels of the organization including Laboratory Technicians, Staff Microbiologists, Production Operators, Quality and Operations Management, and eventually internal and external Regulatory Auditors.
Candidate will also provide subject matter expertise for standard operating procedures and quality standards content, as well as provide gap analysis to ensure that these programs are compliant with all regulatory requirements.
ROLE RESPONSIBILITIES
• Under the direction of other SME's, will performs periodic re-qualification of laboratory and production sterilization systems, interpret and evaluate data in terms of accuracy, precision, trends and potential GMP impact, and recommends appropriate corrective actions.
• Meet with group to review performance of lab and production equipment, recommend improvements, and develop and implement changes to processes.
• Act with others to drive continuous improvement within the team and across departments.
• Provide subject matter expertise and oversight of the daily activities of technical level colleagues. After a period, may train others in the theory and practice of one or more of sterilization technologies.
• Independently will write SOPs, technical reports, project plans, etc.
• Apply existing techniques and procedures, with recommendations, and implement modifications for improved efficiency.
• Will need to be able to recognize atypical data, inform supervision of relevant problems, and with assistance implement solutions.
• Contribute to the completion of specific team objectives and assigned project milestones.
• Candidate will be required to complete aseptic gowning certification (Grade B) in order to enter aseptic manufacturing areas to place and retrieve biological indicators, participate in media fill observation, and function as smoke study observer.
Off-shift and weekend work may be required based on business needs.
QUALIFICATIONS
BS/MS in Microbiology, Bacteriology or related biological science is required.
Understanding of aseptic laboratory techniques is essential.
One to two years of previous experience in industrial and/or aseptic pharmaceutical production environment preferred.
The successful candidate will have good planning skills, good oral and written communication skills, and a knowledge of fundamental microbiology principles.
Preferred candidates display a technical knowledge of one of these microbiological disciplines: Sterilization Validation or Environmental Monitoring of a Pharmaceutical Cleanroom Environment (viable and non-viable). Would also be helpful to have experience in one or more of the following areas: Aseptic processing, Biological indicator testing, Sanitization, or Container Closure Integrity Testing (CCIT).
Experience using Lean, Six Sigma, and other continuous improvement methodologies for process improvement is highly desirable.
PHYSICAL/MENTAL REQUIREMENTS
Job duties can be physically demanding, including heavy lifting, spending hours on your feet, working at heights, and confined space entry.
Job duties may also involve sitting for extended periods while working at computer terminal.
Will be required to complete and maintain aseptic gowning certification (Grade B) in order to enter aseptic manufacturing areas.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Job may require working off shift at times, and/or some travel. Must be able to be grade B aseptic gowning qualified.
ORGANIZATIONAL RELATIONSHIPS
This role will require interactions with QA, operations, lab personnel and management at all levels in both DP and API.
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.
