U-05 Sterile Product Specialist B – 2nd Shift (3:00pm-11:30pm)

<p><b>Why Patients Need You</b></p><p>Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.</p><p></p><p><b>What You Will Achieve</b></p><p>The Sterile Process Specialist (SPS) is responsible for the manufacturing (micronizing, formulation and filling) of aseptic products. In addition, the selected candidates will be responsible for cleaning, preparing and sterilizing equipment and components needed in the manufacturing of aseptic products.</p><p></p><p>Strictly following procedures, guidelines and site policies is a requirement of the position.</p><p></p><p><b>How You Will Achieve It</b></p><p>The essential duties for this position include but are not limited to:</p><ul><li>Performs all tasks as outlined in batch records, procedures, and job aids.</li><li>Legibly records data in batch records, logs and other GMP documentation.</li><li>Verifies materials and equipment against the batch record and assures materials are correct and approved.</li><li>Supplies components, equipment and miscellaneous items to the manufacturing area as needed to maintain the production schedule.</li><li>Performs checks, calculations and completes documentation as required to comply with procedures.</li><li>Operates, cleans, lubricates, services, and makes minor repairs/adjustments to production equipment.</li><li>Labels, dispenses and samples materials.</li><li>Performs calibration verifications on production equipment.</li><li>Accurately weighs, measures, mills and dispenses ingredients in accordance with batch records and procedures.</li><li>Cleans and sterilizes process equipment using clean-in-place (CIP) and steam-in-place (SIP) systems.</li><li>Assembles, operates, cleans and troubleshoots micronizing, formulation and aseptic filling equipment.</li><li>Cleans, assembles, prepares and sterilizes equipment.</li><li>Maintains a high level of cleanliness and housekeeping of all manufacturing areas.</li><li>Performs other duties as assigned by supervision.</li></ul><p></p><p><b>General Expectations</b></p><ul><li>Work in a safe manner and report all potential safety issues to leadership in a timely manner.</li><li>Perform all tasks in strict compliance with operating procedures, best practices and regulatory requirements.</li><li>Dependable - Follows unit / area / plant requirements and guidelines.</li><li>Willing to assist other production units in order to meet unit / site goals.</li><li>Maintain Pfizer Learning System (PLS) training at or above 98%.</li><li>Perform a variety of miscellaneous tasks in support of the Rochester Site objectives.</li></ul><p></p><p><b>Communication and Leadership Expectations</b></p><ul><li>Consistently displays behaviors in accordance with Pfizer Core Competencies: Seizes accountability; grows self; change agile; self-awareness; commits to one Pfizer; peer relationships.</li><li>Train and mentor new colleagues and contracted resources.</li><li>Provide feedback to leadership regarding issues and errors with GMP documentation.</li><li>Understands basic problem-solving methods (Method 1 training).</li><li>Coordinates with maintenance to complete repairs and develop solutions to equipment issues.</li></ul><p></p><p><b>Training Step Progression Requirements:</b></p><p><b>Position</b></p><ul><li>Sterile Process Specialist (SPS) 1– Prep Area.</li><li>Sterile Process Specialist (SPS) 2 – Bulk Formulation.</li><li>Sterile Process Specialist (SPS) 3 – Micronize API.</li><li>Sterile Process Specialist (SPS) 4 – Filling.</li></ul><p></p><p><b>Starting wage classification</b></p><ul><li>= Sterile Machine Operator (SMO) (&lt; Aseptic Service Technician (AST)).</li><li>= Aseptic Service Technician (AST) (&gt;Sterile Machine Operator (SMO)).</li><li>&gt; Aseptic Service Technician (AST) &amp; &lt; Packaging Machine Operator (PMO).</li><li>= Packaging Machine Operator (PMO).</li></ul><p></p><p><b>Training activities on this level</b></p><p></p><p>Activities performed in Grade D &amp; Grade C rooms, such as but not limited to:</p><ul><li>Clean parts, wrap parts, materials transfer, run sterilizer / UV, restock materials, test <span><span>filters/suits/gloves,</span></span> tub feeder etc.</li><li><b>All of SPS 1 PLUS: </b>Clean-in-place (CIP) and steam-in-place (SIP), gel, formulate, unload sterilizer, etc.</li><li><b>All SPS 2 PLUS: </b>Install suits, set up micronizer, Micronize, dispense API, TD/CU micronizer etc.</li><li><b>All SPS3 PLUS: </b>Set up filler, run filler, TD/CU filler, fill check.</li></ul><p></p><p><b>Driver for <u>qualification (signed off) </u>on this level</b></p><ul><li>Qualified in all Sterile Process Specialist (SPS) 1 activities.</li><li>Aseptic <span>go