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DATE ADDED: Sat 02/11/2019

Technical Operations Specialist

Cloughmills, UK


JOB TYPE: Permanent, FullTime

**Orion Group are looking for a Technical Operations Specialist for our multinational pharmaceutical client based in the Cork area on an initial 12-month contract with the potential to extend.**

**Job Purpose**
Active engagement with the Technical Operations team, delivering a successful outcome to all Technical Operations activities using Good Manufacturing Practices (GMP). These activities include, but are not limited to, Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Cleaning Validation, Process Validation, Change Control, Exception/Event Investigations/Closure.

**Main Responsibilities of the role**

- Conduct Technical Operations activities in compliance with US and EU regulations, client procedures and EHS&S requirements
- Develop Technical Operations documentation as required (e.g. strategies, plans, protocols, procedures, reports)
- Review and approve documents prepared by the Technical Operations
- Execute Technical Operations protocols as required
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports
- Prepare reports for executed protocols for review and approval
- Initiate and implement change control activities in accordance with site procedures
- Track and resolve exceptions/events/deviations during Technical Operations activities
- Prioritize Technical Operations activities in line with the project schedule
- Co-ordinate Technical Operations activities with engineering, construction and commissioning activities
- Co-ordinate Technical Operations activities with contractors and vendors as required
- Co-ordinate Technical Operations document review and approval
- Collate and organize Technical Operations files for turnover to QADC
- Attend identified training, required to fulfil the role of a Technical Operations Specialist
- Assist in the development of training material for Technical Operations activities
- Participate in cross-functional teams as required
- Deputise for the Technical Operations Lead or other team member where required

**Desired Experience and Background of the successful candidate**

- Bachelor's Degree in a scientific/technical discipline required
- Focus on patients and customers at all times
- Experience in Validation (e.g. Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Cleaning Validation, Process Validation)
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals
- Ability to apply cGMP regulations and guidelines to all aspects of Technical Operations activities
- Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities
- Excellent interpersonal skills
- Attention to detail
- Good problem-solving skills
- Results and performance driven
- Adaptable and flexible

* * *

Our role in supporting ***diversity*** and ***inclusion***
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
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