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Austin, TX 78728
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Job Details

This role will be focused on driving the enhancement of the technical and scientific knowledge levels within the three manufacturing groups, influencing best practice around Sterilisation and Depyrogennation processes across all Manufacturing areas, while also providing complete oversight which includes protocol reviews, document approvals, change controls, SOP revisions and training under the guidance of the Sterilisation and Depyrogenation Processes GSME lead.The LSME role is a leadership position within the site and will have two key phases relating to the training and qualification to become the SME:

LSME training support:

The initial phase will be focused on the education programme for each specific LSME with the intent to enhance their technical and scientific understanding and capabilities and be accountable for their success. This will include on the job coaching and may require the SME to visit other manufacturing sites as part of their learning program.

Systems will be in place to provide on-going feedback to the LSME on their development and performance to enhance their understanding and growth.

Execution of LSME role:

The LSME will support site colleagues in fulfilling their daily roles, including coaching individuals/teams around decision making paths when issues arise. The LSME will co-approve key documents such as SOPs, validation protocols, risk assessments, investigations, and change controls which are applicable to the LSME's responsibility.

The LSME will also be involved supporting the implementation of actions arising from internal and external assessments, coach teams on the associated root cause investigation, design and implement solutions, and where applicable, be involved in the assessment and critical evaluation of validation and/or SOP updates, training and the review of effectiveness of actions. In partnership with global SME's, they will also be required to complete assessments of all operations within the LSME's scope, identify improvement opportunities and prioritise actions to address opportunities.

The LSME will be required to assist with the enhancement of technical and scientific knowledge in updates to documentation and explain the reasons for changes within the "why, what, when, who and how" questions. Where appropriate, SOP redesign will include the use of PHP Document Design principles and tools to drive a more user friendly procedural format. The LSME will have a strong understanding of the IKKT Quality Improvement Plan (QIP) to be able to support any initiatives to review/enhance SOPs and training modules within their area of responsibility and where required, offer suggestions to simplify and improve.

In the maintenance phase the LSMEs will be an established participant within Pfizer network forums (e.g. global common interest groups, communities of practice, Aseptic Quality Forum, etc.) and if applicable industry working groups to maintain currency with knowledge and understanding.

During the support program, the site's Talent Management process will identify succession candidates for each LSME position and these individuals will receive ongoing coaching in the LSME role to ensure the standard of technical knowledge is sustained.

The Sterilisation and Depyrogenation Processes LSME will be responsible for the coaching and mentoring of production personnel. They will be required to have a comprehensive understanding of procedures, behaviors, trending and issues so as to assist and coach the production teams. The details of the Sterilisation and Depyrogenation Processes LSME are defined as follows:

+ Autoclave load design

+ Autoclave and Depyrogenation Tunnel Operation including loading, management of alarms, cycle parameters checks and dryness checks.

+ Understanding principle of operation and CPP for each process.

+ Autoclave/Vial Washer/Depyrogenation Tunnel Validation, periodic requalification and daily function testing (Leak rate test, Bowie Dick, etc

+ Validation of sterilisation of lyophiliser chambers

Validation of SIP systems (eg product transfer lines)

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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