Description
Position Title:
MSAT Engineer
Department:
Manufacturing Science and Technology (MSAT)
Reports to:
MSAT Manager
Position Summary:
We have a great opportunity for a MSAT Engineer to join our MSAT Validation team.
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.
* Prioritise MSAT activities in line with Manufacturing / project schedules.
* Co-ordinate MSAT activities with contractors and vendors as required.
* Attend identified training, required to fulfil the role of a MSAT Engineer.
* Participate in multi-functional teams (project, investigations) as required.
Key Skills and Proficiencies Required:
* Excellent interpersonal skills.
* Ability to operate as part of a team is essential.
* Proven leadership skills and critical thinking ability.
* Excellent communication skills both written and verbal.
* 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.
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).
* 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.