Senior Bioprocess Technician
About The Position
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. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them. ROLE SUMMARY The Senior Bioprocess Technician leads the execution of Commercial, Clinical, and/or Development production according to Standard Operating Procedures and Production Schedule. The Senior Bioprocess Technician will work on interdisciplinary teams, to own and implement process improvements, and lead/participate in process troubleshooting. What You Will Achieve Leads manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation. Follow SOPs and batch records for unit operations. Point of Contact for the execution and issue resolution associated with process equipment commissioning, qualification and validation. Owns troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor. Delivers Right first time execution and continuous improvement, the timely review of daily documentation and completes data entry; Monitor, Identify and/or Communicate process and compliance trends in real time. Partners with area Process Engineer for audits and walkthroughs and observation improvements, as needed. Participate in the authoring role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc. Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations. Responsible for remaining current on assigned training. Leads Lean Manufacturing, Sustainability and Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas. Leads in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk. Generates work requests when issues arise with facility / manufacturing equipment. Provides support to maintenance to facilitate resolution, when needed. Point of contact for emergency work orders. Skilled in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS. Leads and participates in performance of cleaning, inventory, and maintaining facility in a safe and GMP compliant manner. Identifies the need for escalation through various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.
Requirements
- High School diploma and 6 years of relevant experience required.
- Associate plus 4 years of relevant work experience
- Bachelors plus 2 years of relevant work experience preferred
- Experience within the biopharmaceutical industry, including knowledge and experience with relevant biopharmaceutical unit operations and/or laboratory operations
- Understanding of continuous improvement processes
- Proficiency in process equipment, systems, manufacturing operations, and automation control
- Ability to manage personal time and professional development
- Strong problem-solving skills with the ability to identify and resolve potential issues
Nice To Haves
- Bachelor's Degree
- Advanced knowledge of biopharmaceutical manufacturing processes
- Strong communication and interpersonal skills
- Proficiency in project management
- Familiarity with global regulatory and environmental guidelines
- Ability to adapt to changing priorities and work effectively under pressure
- Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity
Responsibilities
- Leads manufacturing operations on the production floor for buffer/media make-up tanks, glass washers, autoclaves, bioreactors / fermentors, drug product filling, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids with varying levels of automation.
- Follow SOPs and batch records for unit operations.
- Point of Contact for the execution and issue resolution associated with process equipment commissioning, qualification and validation.
- Owns troubleshooting, technical support/analysis and resolution of equipment, automation, and process issues on the manufacturing floor.
- Delivers Right first time execution and continuous improvement, the timely review of daily documentation and completes data entry; Monitor, Identify and/or Communicate process and compliance trends in real time.
- Partners with area Process Engineer for audits and walkthroughs and observation improvements, as needed.
- Participate in the authoring role for controlled documentation; SOPs, Manufacturing Batch/Formulation Records, Forms, etc.
- Collaborates with the Subject Matter Expert for manufacturing operations in support of QTS investigations and CAPA implementations.
- Responsible for remaining current on assigned training.
- Leads Lean Manufacturing, Sustainability and Operational Excellence initiatives; facilitate the drive towards continuous improvement in all manufacturing areas.
- Leads in the escalation process through various levels of management when operations, personnel safety, equipment functionality, product supply and/or quality compliance are at risk.
- Generates work requests when issues arise with facility / manufacturing equipment.
- Provides support to maintenance to facilitate resolution, when needed.
- Point of contact for emergency work orders.
- Skilled in enterprise systems to support manufacturing operations including but not limited to, SAP, LIMS, AMPS, PDOCS and/or QTS.
- Leads and participates in performance of cleaning, inventory, and maintaining facility in a safe and GMP compliant manner.
- Identifies the need for escalation through various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.
Benefits
- eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
