Use Your Power for Purpose

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizer’s mission. You will help to ensure that patients and physicians have the medicines they need when they need them. The significance of your role cannot be overstated, as it directly influences the availability of essential medications. Your dedication and agility are crucial in maintaining the high standards of our manufacturing processes. By continuously striving for excellence, you contribute to the overall mission of delivering life-saving treatments to those in need. Your commitment to improving outcomes ensures that our breakthroughs reach the patients who depend on them.

The Operations Specialist I is responsible for providing detailed technical training to Drug Product work team colleagues. Liaison between work team and maintenance for repairs and preventative maintenance. Develop, maintain and train work team colleagues on operator care task sheets. Establish efficient processes, monitoring specific results, and improve identified process opportunities using Right First Time (RFT) and Lean principles. Maintain manufacturing equipment at optimal operating efficiency. Assist in identifying problems and solutions using Method 1 and Quality Risk Management (QRM). Serve as technical subject matter expert for the work team and Deviation Report Coordinator (DRC) on equipment related deviations. Work with engineering by participating in developing equipment specifications, user requirements, capital scope development, FAT/SAT support and qualification activities. Work with procurement and packaging engineering to monitor component issues and conduct feasibility assessments/line trials as needed.

What You Will Achieve

• Functional/Technical Knowledge: Limited knowledge of industry practices and standards. Proficient in computer applications such as MS Word, Excel and Outlook.

• Problem Solving and Innovation: Develop solutions to routine problems following established Pfizer policies and procedures.

• Discretion, Latitude, Level of Independence: Ability to work independently. Follows specific, detailed instructions.

• Impact and Organizational Contribution: Contributes to the completion of routine tasks. Failure to achieve results will have significant impact on departmental objectives.

• Time Span of Work: Daily tasks and deliverables. Results can usually be measured on daily or weekly basis.

• As directed by supervision, the Operations Specialist may be responsible for day to day floor operations, daily line assignments, serving as person in charge in the absence of a Production Lead and/or Supervisor, attending scheduling meetings, filling out the daily shift report, writing QAR’s, writing PTVA’s, OEE, and reviewing and requesting SOP and document revisions. Work responsibilities will require entry into the aseptic area and will include aseptic gowning requirements.

• Teamwork/Influence: Contacts are primarily within immediate work group or within normal process-related work flow, but interactions with other units will also be required.

Here Is What You Need (Minimum Requirements)

• High School Diploma or GED

• 4+ years of experience

• Strong oral and written communication skills

• Proficiency in current Good Manufacturing Practices (cGMPs)

• Experience in pharmaceutical manufacturing or a related field

• Ability to troubleshoot and resolve technical issues

• Strong organizational skills and attention to detail

• Capability to work independently and as part of a team

• Proficiency in using standard office software and manufacturing systems

Bonus Points If You Have (Preferred Requirements)

• A Bachelor's Degree

• Experience with Lean Manufacturing principles

• Knowledge of regulatory requirements and quality standards

• Familiarity with Pfizer's Learning Solution and Quality Tracking System

• Ability to adapt to changing priorities and manage multiple tasks

• Ability to train and mentor less-experienced colleagues

• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity