Technical Operations Specialist

Job Category:
Technical Support - L 1, 2,3
Job Type:
Contract
Level of IT Experience:
5-10 Years
Area:
Cork
Location:
Cork
Salary Description:
Competitive salary offered
Posted:
07/10/2019
Recruiter:
Anonymous
Job Ref:
769251117

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 requiredDesired 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 flexibleOur 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

Contact Details:
Anonymous
Contact: Contact

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