LSC have a great opportunity for a Process Validation Associate working for our biopharmaceutical client in a state of the art manufacturing facility in Cork.
SCOPE
The candidate will have a significant role in the approval of documentation and support for release of manufacturing systems and processes for cGMP use. This position is required to successfully complete projects in a timely manner supporting company goals and objectives.
RESPONSIBILITIES
* Perform process validation activities related to drug substance and drug products, through defined clinical and commercial stages.
* Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising supervised judgment within broadly defined procedures and practices to establish acceptance criteria, and to identify and implement solutions to meet company and Health Authority requirements.
* Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
* Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
* Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures.
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EDUCATION
Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
Training in project management is preferred
EXPERIENCE
* 2+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
* Organizational and management skills to participate in multi-discipline project groups
* Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate.
* Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations.
* Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations.
* Proficiency with technical writing expected.
* Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications is highly beneficial.
Apply directly through this advert or call Kathy Gillen on 021 4718212 fro more detalis.
All applicants must have a 12 month valid work visa for Ireland. LSC does not provide sponsorship for work visas.
