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Cleaning Validation Specialist

  • Job reference: 924990
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 18/04/2019

Orion Group are recruiting a Cleaning Validation Specialist on behalf of one of our Multinational Medical Device Clients based in Cork on an initial 12 Month Contract.

Role: Technical Operations Cleaning Validation Specialist (12 months)

Job Purpose
We have an exciting opportunity for a Technical Operations Specialist to join our expanding team in Cork to help support the Technical Operations unit.
The Technical Operations Specialist will be responsible for the following.
Active engagement with the Technical Operations team, delivering a successful outcome to all Technical Operations activities using Good Manufacturing Practices (GMP). The primary responsibility will be Cleaning Validation. Other activities may include Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), Process Validation, Change Control, Exception/Event Investigations/Closure.
You will have fulfilled the educational requirements for this role.

Requirement's:
* Excellent interpersonal skills
* Ability to operate as part of a team is critical.
* Customer focus
* Innovative
* Excellent communication skills both written and verbal
* Attention to detail
* Good problem-solving skills
* Results and performance driven
* Adaptable and flexible
* Integrity, trustworthiness and objectivity
* Knowledgeable of FDA/EMEA regulatory requirements

As a Technical Operations Cleaning Validation Specialist, your typical day may include:

  • Conduct Technical Operations activities in compliance with US and EU regulations, JSI 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 fulfill 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.
  • Domestic and international travel may be required.

  • To Bachelors Degree in a scientific/technical discipline required
  • Focus on patients and customers at all times.

Desirable:

  • 5+ Years Cleaning Validation Experience.
  • Experience in a large molecule start-up facility.
  • Experience in other Validation areas (e.g. Performance Qualification (e.g. Steam-In-Place PQs), Process Validation Support (e.g. Mixing Studies, Media Challenge), 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.

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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