Aseptic Development Professional - Night Shift

Why Patients Need You

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.

What You Will Achieve

The primary responsibility of the Aseptic Development Professional (ADP) is supporting end-to-end ownership of aseptic competency, integrating formal training with real-time, on-the-floor coaching and verification of behaviors.

This role ensures that aseptic personnel are trained correctly, performing correctly on the floor, and sustaining correct behaviors over time.

ADPs act as the bridge between training, quality standards, and manufacturing execution, ensuring alignment with site SOPs, global procedures, and regulatory expectations.

How You Will Achieve It

• Support the aseptic training program and environment

• Provide coaching, behavioral reinforcement and modeling within the aseptic processing areas and support aseptic SME team members to ensure flexibility and maintain engagement in aseptic operations

• Administer qualification, certification, and competency verification of aseptic gowning and processes

• Monitor the effectiveness of the aseptic training process and implement data-driven improvements

• Ensure remediation and continuous improvement support for failed gowning qualifications and aseptic behavior deviations

• Integrate aseptic gowning training principles with practices in the manufacturing areas

• Utilizes appropriate training delivery methods including on-the-job, small groups, classroom training, and knowledge-based training, to deliver aseptic learning courses as part of a qualification program to assist in developing a competent aseptic workforce

• Complete training records appropriately and manage training information within the Learning Management System

• Regularly evaluate the effectiveness of the learning and development programs and provide recommendations for improvement

• Ensure aseptic training areas are maintained in a constant state of compliance and audit readiness

• Support ownership of the aseptic coaching program ensuring cross-functional alignment with operations, biological quality, quality assurance, and compliance

Qualifications

Must-Have

• 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

• Must be able to gown aseptically and retain certification

• Ability to handle multiple projects in a fast-paced environment

• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards and FDA regulations

• Pharmaceutical operations experience and/or knowledge

• Effective oral and written communication, presentation and interpersonal skills

• Working knowledge of PC and Software (MS Office)

• Strong analytical skills, capable of organizing and analyzing data from multiple sources and extracting key information to achieve goals

• Ability to interface with multiple levels of people in the organization, including plant personnel and senior management

Nice-to-Have

• 5+ years of pharmaceutical experience with a basic understanding of aseptic manufacturing processes

• Strong critical thinking skills to assess incidents that may impact the aseptic environment or processes and provide input and guidance to avoid or mitigate the associated risks

• Yellow-belt training/certification

• Experience writing and managing deviations

• Advanced knowledge of FDA and EU regulations

  
 

PHYSICAL/MENTAL REQUIREMENTS

• Capable of aseptic gowning

• Able to function in stressful situations, while remaining focused on the necessary requirements.  In addition, must be able to identify and escalate issues in a timely manner 

• Job duties involve occasional lifting (less than 35 lbs.), reaching, and sitting while working at computer terminal

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Onsite A/B shift assignment on Night Shift

• Must be willing to work beyond the hours typically defined as a ‘regular’ workday which may or may not include weekends and holidays

• Stand for up to 8 to 12 hours depending on assigned area.

• Successful candidate will be required to complete various levels of gowning certification to enter and support the manufacturing areas. 

• No routine travel

Other Job Details:

• Last day to apply: August 16th

The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Quality Assurance and Control