MSAT Engineer

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded
in 1996, headquartered in Pomona, California, USA, with Global operations in
Ireland, India, Singapore, Australia and the US, serving 350 clients in more
than 23 countries worldwide. We provide cloud -based software solutions for
Quality Management and Regulatory Inspections, pharmaceuticals contract
manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model
by aligning our EVP as one of the unique selling point which includes the
opportunity to work with the most talented cohort of like -minded professionals
operating in the Pharma/ Biotech Industry. We offer a permanent contract of
employment giving exposure of working in Top Pharmaceutical client sites in a
diverse -cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in -house training mentorship through constant guidance to facilitate career
progression. We believe in creating high performing teams that can exceed our
client’s expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our deliverables
are being met.

Overview:

• 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).
  
  

Requirements

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.
   
  

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).
  
• 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.