Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
The Sterile Products Specialist (SPS) is responsible for performing various Manufacturing operations, including but not limited to, equipment cleaning and sterilization, dispensing of active pharmaceutical ingredients and excipients, micronizing, compounding bulk products and aseptically filling final containers. In addition, the selected candidates will be responsible for performing set-up activities, operates, troubleshoots and cleans equipment and facilities to achieve production schedules. Manufacturing Penicillin syringe products in accordance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOP), or other written or oral instructions.
How You Will Achieve It
Essential Duties and Responsibilities:
The essential duties for this position include but are not limited to:
- Performs all tasks as outlined in batch records, procedures, and job aids. Legibly records data in batch records, logs and other GMP documentation.
- Verifies materials and equipment against the batch record and assures materials are correct and approved.
- Supplies components, equipment and miscellaneous items to the manufacturing area as needed to maintain the production schedule.
- Performs checks, calculations and completes documentation as required to comply with procedures.
- Operates, cleans, lubricates, services, and makes minor repairs/adjustments to production equipment.
- Labels, dispenses and samples materials. Performs calibration verifications on production equipment.
- Accurately weighs, measures, mills and dispenses ingredients in accordance with batch records and procedures.
- Cleans and sterilizes process equipment using clean-in-place (CIP) and steam-in-place (SIP) systems.
- Assembles, operates, cleans and troubleshoots micronizing, formulation and aseptic filling equipment.
- Cleans, assembles, prepares and sterilizes equipment.
- Maintains a high level of cleanliness and housekeeping of all manufacturing areas.
- Performs other duties as assigned by supervision
- Work in a safe manner and report all potential safety issues to leadership in a timely manner
- Perform all tasks in strict compliance with operating procedures, best practices and regulatory requirements
- Dependable - Follows unit / area / plant requirements and guidelines
- Willing to assist other production units in order to meet unit / site goals
- Maintain training at or above 95%
- Perform a variety of miscellaneous tasks in support of the Rochester Site objectives
Communication and Leadership Expectations
- Consistently displays Own-It behaviors in accordance with Pfizer Core Competencies: Seizes accountability; grows self; change agile; self-awareness; commits to one Pfizer; peer relationships.
- Train and mentor new colleagues and contracted resources
- Provide feedback to leadership regarding issues and errors with GMP documentation.
- Understands basic problem solving methods (Method 1 training)
- Coordinates with maintenance to complete repairs and develop solutions to equipment issues.
- High school diploma / general education degree (GED)
- Math and reading skills required for SOP, GMP and Batch Record comprehension.
- Ability to contribute to department success in a team environment and perform tasks at a productive level under demanding conditions is mandatory.
- Must be self-motivated and willing to learn new and changing responsibilities. Requires a demonstrated ability to direct daily activities to meet production schedule.
SAFETY CONSIDERATIONS Cannot be Type 1 allergic to Penicillin Position requires adhering to the manufacturing safety requirements outlined in the site Safety SOP'S Requires the use of chemical protection, eye protection, hearing protection, and foot protection.
WORKING CONDITIONS Requires bending, reaching, lifting, using both hands, standing for extended periods of time, and having corrected vision of 20/20 Must be able to lift and move equipment, i.e. drums, tote boxes, bags, etc Requires the ability to garb for lint controlled and sterile areas as well as the mobility to travel about manufacturing areas Requires flexibility regarding overtime, including before and after shifts as well as on weekends.
MACHINES/EQUIPMENT USED Balances, scales, calculators, pH meters, mixers, UV pass through, drum lifter; power and hand trucks, filling equipment, capping and washing equipment, shrink banding, automated inspection equipment, labeling and transfer equipment, Kaye recorders, autoclaves, sterilization tunnels, computerized fill check systems, automated filter integrity testing equipment, and other computer interfaces
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
• Notifies supervisor of' downtime and equipment/component-related problems.
• Supplies machines and workstations with materials, labels, supplies, and removes them from equipment and immediate area.
• Keeps equipment and work area clean and orderly.
• Assists in the training of new colleagues.
• Performs checks, adjusts pH values, records temperatures and completes verifications as required. Performs calculations. Documents to the Rx card as necessary. Prepares bulk and intermediate solutions.
• Maintains identity and segregation of cleaned and sterilized equipment.
• Performs and verifies filter integrity test.
• Performs residual testing (equipment, sterile, and non-sterile manufacturing moms).
• Assists Management with product investigation deviations
This is a union position; membership in union is optional.
Work Location Assignment:On Premise
Last Date to Apply: October 5, 2022
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.