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 clients 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.