Why Patients Need You

Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need.

What You Will Achieve

The successful candidate will assume professional responsibilities within the API (Active Pharmaceutical Ingredient) compliance group.  Primary responsibilities include managing all cleaning and process validation activities and documentation for their assigned manufacturing areas.Analyzes and designs sequences of operations and workflow to improve the company’s changeover systems within regulations and cGMP guidelines.

Activities may include process monitoring, safety and environmental improvements, troubleshooting, documentation updates, and cleaning process reliability improvements.  In addition, the candidate may support the compliance team with customer and regulatory audits and evolve compliance programs in their area with direction from API compliance team.

How You Will Achieve It

In this role, you will:

• Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.
• Support plant operations with timely responses to complex validation concerns or cleaning failures.This position provides support during non-routine business hours requiring 24/7 on call accessibility.
• Support API wide compliance initiatives.
• Provide routine documentation updates through change control.
• Conduct and support Environment, Health & Safety, and quality-based investigations.
• Generate metrics, trend data, and develop solutions to challenges.

Qualifications

Must-Have

• Applicant must have a bachelor’s degree with 0+ years of experience; ORan associate’s degree with 4 years of experience; OR a high school
  diploma (or equivalent) and 6 years of relevant experience.
• Demonstrated ability to lead people and processes.
• Effective written and oral communication.
• Knowledge of Microsoft Applications.

Nice-to-Have

• Experience in indirect leadership roles such as testing, team Subject Matter Expert, project lead, or training lead
• Demonstrated proficiency in computerized systems, with hands-on experience using Laboratory Information Management Systems and Quality Tracking Systems
• Ability to manage multiple tasks and projects simultaneously
• Experience with Good Manufacturing Practices (GMP) and regulatory compliance
• Proficiency in data analysis and process improvement techniques

PHYSICAL/MENTAL REQUIREMENTS

• Physical Demands:  Frequent time in both manufacturing and office environments. 
• The manufacturing environment includes equipment with moving parts. 
• Must be able to perform gowning requirements for entry in the manufacturing areas.
• Requires lifting, sitting, standing, walking, stair climbing and roof access. 
• Work Environment:  Office environment, with frequent time in the manufacturing areas.  Possible exposure to high noise environments, solvents, and pharmaceutical ingredients.  Use of hearing and eye protection is required. 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Schedule is 1st shift, Monday - Friday. Must be available to support 24/7 – 365 days operation. 

Work Location Assignment: On Premise

OTHER JOB DETAILS

• Last Date to Apply for Job: January 24, 2025
• Referral Bonus Eligibility: YES
• Eligible for Relocation Package: NO

The annual base salary for this position ranges from $58,500.00 to $97,500.00. 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.

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