Media Fill - Aseptic Engineer

Role Summary

The Sr Tech Ops Aseptic Engineer provides strategic direction and technical expertise for site media fills and airflow visualization studies/qualification. To include coordination and execution as well as maintenance of the periodic requalification schedule. This role serves as a Center of Excellence, driving alignment with global and industry engineering standards. The engineer supports site changes of existing processes while also supporting capital project execution. The position plays a key role in shaping the site’s media fill and airflow visualization program, ensuring operational excellence, and fostering a self-sustaining technical work structure for the Focus Factory Manufacturing Technology teams for overall success.

Responsibilities

• S/he acts as the SME for aseptic programs related to Media Fills and Airflow Visualization. Individual must have knowledge and application experience related to Aseptic processes with experience supporting Media fills and/or Airflow Visualization.
• S/he will be expected to work routinely with cross functional groups throughout the site for execution, improvements and ongoing changes. S/he must have a solid understanding and knowledge of pharma regulations and cGMP principals and demonstrated ability to apply knowledge to program improvements and changes. Person will be responsible for interfacing with auditors and presenting on site processes.
• S/he organizes, coordinates and supports testing associated with the development of new process technologies and the support of new systems introductions as it relates to Media Fills and Airflow Visualization efforts. S/he works closely with site Quality and Engineering resources to ensure appropriate maintenance of site systems is achieved and maintained against procedures and industry guidance. S/he plans, generates, reviews and approves site technical reports, to include qualification plans/protocols, design specs, Risk Assessments.
• S/he will be expected to ensure site alignment to global procedures and work instructions related. Provide ongoing training, guidance and templates to support the technical teams within the Focus Factories in successful execution of Media Fills and Airflow Visualization efforts.
• S/he will be expected to confirm pre-requisites are met and supported by approved documentation in accordance with procedures and industry standards. Oversee and assist team members and contractor resources with their assigned projects. Support development and design of strategies, studies, draft and/or review project validation plans and documentation.
• S/he to provide input in risk assessments and/or quality deviation investigations to identify root causes and define correction and/or preventive actions (CAPA) related to failures. Author and/or review risk assessment documents. Review investigations, commitments, procedures, and batch records. Provide technical input and complete SME impact assessment to proposed change controls vetted for implementation. Participate in teams assembled to complete change control implementation for new and existing systems.

Minimum Requirements

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
• Knowledge/understanding of media fill and/or airflow visualization requirements/execution.
• Strong knowledge of Aseptic filling practices and regulations.
• Solid leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.
• Must be self-motivated and work with little direction
• Good interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments.
• An aptitude for understanding process technology, decision making ability, and excellent oral and written communication skills are essential. Demonstrated ability to interact effectively with multiple levels of the organization. Candidate must possess flexibility to respond to changing conditions and priorities.
• Understanding of global regulations on GMP processes.

Physical/Mental Requirements

• Remains organized & positive in ambiguous and fast-paced, rapidly changing environment
• Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.
• Ability to process complex information and make recommendations with incomplete data set
• Ability to adjust work schedule to meet business needs ‚Äì overtime, off shift, weekends.
• Ability to travel
• Able to stand for extended hours for test runs and performance monitoring of processes ‚Äì will include working within special gowning for cleanroom access
• Able to climb ladders/steps
• Able to lift items of 25lbs
• Strategic thinker for issue resolution

Additional Requirements

• Pfizer operates 24/7 across most of the business units. Employee must have the ability to work extended hours, holidays and/or weekends as needed. Limited travel may be required to support OEM equipment design reviews and/or Factory Acceptance Testing of new equipment. Employee will be expected to periodically work within clean room areas requiring special gowning.