MSAT Specialist- Thermal

Kenny-Whelan (a specialist division of the CPL group) are hiring a MSAT specialist -Thermal Validation to work on contract at Janssen Sciences in Ringaskiddy Cork

MSAT Specialist – Thermal (12 months)

Location: Ringaskiddy, Cork, Ireland

Reports to: Manager, Manufacturing Science & Technology

Position Summary:

We have an exciting opportunity for a MSAT Specialist to join our Validation team in the Manufacturing Science & Technology department at the Ringaskiddy site.

The role is integral to driving successful outcomes in various MSAT activities, primarily focusing on Thermal Validation – Autoclave cycle development and validation and SIP. Secondary activities include, but are not limited to, Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges, ILC Verification Studies, Chemical Hold Studies).

Main Duties & Responsibilities:

• Execute MSAT activities in compliance with US and EU regulations, JSI procedures and EHS&S

requirements.

• Develop and maintain MSAT documentation such as strategies, plans, protocols, and reports.

• Analyse process data, troubleshoot issues, and collaborate with cross-functional teams.

• Review and approve documents prepared by MSAT colleagues.

• Prepare reports for executed protocols for review and approval.

• Liaise with Manufacturing to provide support where required with routine operations /

project-based work.

• Initiate and implement change control activities in accordance with site procedures.

• Investigate and resolve exceptions/events/deviations during MSAT activities.

• Participate in identified training sessions essential for fulfilling the role of an MSAT Specialist.

Key Skills and Proficiencies Required:

• Excellent interpersonal skills.

• Excellent communication skills both written and verbal.

• Ability to operate as part of a team is essential.

• Attention to detail.

• Innovative with great problem-solving skills.

• Results and performance driven.

• Adaptable and flexible.

• Integrity, trustworthiness and objectivity.

• Knowledgeable of FDA/EMEA regulatory requirements.

Required:

• Minimum of a degree in a scientific/technical/engineering discipline.

• Focus on patients and customers at all times.

• Experience in validation, manufacturing, quality.

Desirable:

• 2 years validation experience especially in the thermal qualification area

• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or

pharmaceuticals.

MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND- i.e have a valid work permit with 12 months permission + on it

All applications will be treated with the strictest of confidence.

Contact Jenn Dinan on or email the link below