Orion Group Life Sciences are currently recruiting an MSAT Engineer on behalf of our Multinational Biopharmaceutical Client based in Cork on an initial 12-Month contract with potential to extend.

The MSAT Engineer will be responsible for the following.

Active engagement with the MSAT team, delivering a successful outcome to all MSAT validation activities using Good Manufacturing Practices (GMP).

Primary activities are in the Cleaning Validation area. Planning, documenting and performing cleaning validation studies. Leading and/or providing technical guidance for cleaning/ process improvement projects and investigations.

Leading and/or providing technical guidance for process improvement projects and investigations.

Secondary activities include, but are not limited to Thermal Validation, Process support Validation, Supporting process improvement projects, Supporting New product Introduction/ process validation, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations).

Main Duties and Responsibilities:

Conduct MSAT activities in compliance with US and EU regulations, JSI procedures and EHS&S requirements.

Develop MSAT documentation (e.g. strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval.

Review and approve documents prepared by other MSAT colleagues.

Field execution of MSAT protocols.

Liaise with Manufacturing to provide support where required with routine operations / project-based work.

Compile relevant information from contractors, suppliers, and other departments to develop technical reports.

Representing the JSI MSAT site team on platform technical teams.

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

Track and resolve exceptions/events/deviations during MSAT activities.

Prioritize MSAT activities in line with Manufacturing / project schedules.

Co-ordinate MSAT activities with contractors and vendors as required.

Attend identified training, required to fulfill the role of a MSAT Engineer.

Participate in multi-functional teams (project, investigations) as required. Education and Experience:

Required:

A minimum of a Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy or related scientific field is required.

At least 2 yrs experience in the Large Molecule manufacturing industry or equivalent.

Focus on patients and customers at all times.

Desirable:

Experience in Cleaning validation studies and Cleaning strategy (Minimum 2 years).

Also, beneficial would be experience in Thermal Validation, Process Validation, Supporting process improvement projects, Supporting New product Introduction.

Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.

Ability to work independently under general direction, having a good sense of prioritization of goals and good time management.

Ability to lead multi-functional team and to manage complexity and change.

Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.


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