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Position Description: Own and support site’s sterility assurance (SA) and environmental monitoring (EM) programs. Liaise with and advise site functions on all microbiological issues. Ensure that adequate technical information and relevant data is provided to address/remediate SA and EM issues. Ensure that the GMP and regulatory compliance is maintained for all SA, EM and microbiological issues.
Functions, Duties, Tasks:
Own all aspects of EM/SA/microbiology related aspects (e.g. aseptic simulations) on site and ensure the related process remains in a validated state via routine monitoring, reports and PQRs and re-validate the process where appropriate.
Understand site processes, facilities and operations to a sufficient depth to be able to make sound microbiological assessments and decisions when advising the site teams.
Have an overview of the various regulatory and GMP requirements that apply to products and processes, and to have an in depth knowledge of those which have microbiological/SA/EM requirements.
Ensure that the job holder has a working knowledge of microbiological information relevant to the production/QC activities.
Ensure that the microbiology related information in the QC lab is adequate and up to date, including microbiological methods and validations.
Partner with operations and functions to ensure that practices align with the Product Protection Control Strategy, Process Flow Document, GMP, SOPs and existing regulatory commitments.
Manage the aseptic process simulation program and related qualification for all areas on site.
Analyze data on an ongoing basis, to monitor performance with respect to contamination, bioburden, toxins and environmental monitoring using appropriate statistical methods and charts to ensure the process is in control and capable.
Investigate and author deviation investigations, using root cause analysis and other relevant investigative techniques.
Partner with QC, QA, engineering and operations to address routine issues including production, supply, deviations and complaints.
Introduce process changes designed to maintain or improve microbiological and clean room data in line with business needs whilst ensuring no detrimental impact to the product safety, quality and/or regulatory commitments.
Be a technical resource to provide support for: internal and external audits, regulatory documents and changes, scale-up and technical transfer from development, or to contract manufacturing sites.
Routinely analyze the process to identify clean room improvement opportunities and create/maintain a list of potential improvement projects. Work with the process teams to review data, prioritize list of activities and agree implementation plans.
Implement changes via change control and monitor to ensure intended results are maintained and no unintended results or trends occur over time.
Assist in ensuring that all EM and SA related operations are carried out in the most cost effective way according to current safety procedures and regulations
Advise and assist with writing, implementation and evaluation of validation protocols and documents for site processes and laboratory methods.
Partner with operations, QA, QC and engineering with respect to planning, documentation, and commissioning, training and required process/cleaning validation.
Provide written reports on all microbiological issues and be proficient in justifying those reports both internally and externally.
Alternatively a bachelor’s degree in microbiology or similar discipline with minimum 5 years of related demonstrated experience supporting GMP manufacturing.
The role is site based and requires constant interaction with manufacturing and QC functions. The individual should be flexible and a strong team player.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status