Subject Matter Expert – Sterile Fill & Finish Equipment

At Jacobs, we're challenging today to reinvent tomorrow by solving the world's most critical problems for thriving cities, resilient environments, mission-critical outcomes, operational advancement, scientific discovery and cutting-edge manufacturing, turning abstract ideas into realities that transform the world for good.

Your impact

The SME – Sterile Fill & Finish Equipment is generally assigned to a project as someone with specialist skills acquired on the job or through formal qualifications in the field of Pharmaceutical/Life Sciences facilities and equipment. He/she is responsible for client interactions to understand their needs and requirements, creating conceptual options, presentations and getting an “buy in” from clients on an option to proceed further. He/she is also responsible for ensuring that the Company and Group’s technical policies are followed, considering any special contractual requirements.

• Should have a very strong knowledge on layout designing of Injectable Plants and thorough understanding of Sterile Fill Finish Line Equipment along with Lyopholizer Technologies
• Ensure that all work is compliance with the Client’s Standards and Engineering Practices as described in the Project Co-ordination Procedure
• Should possess Expert knowledge on Area classification and man material flow concepts. Should have thorough knowledge on containment techniques and should be aware of carrying out Containment Studies.
• Able to work as an individual contributor to select and size Fill & Finish Equipment and its accessories. Presentations to clients with little or no input from other disciplines at the Feasibility and concept phases.
• Should have in depth knowledge on latest ISPE Guidelines. Should be well aware of regulatory requirements of USFDA, MHRA, EU GMP Annex 1 and WHO etc
  
  
  

Qualification

• Degree in Chemical or Mechanical Engineering from a reputed institute.
  
  
  

Here's what you'll need

• Should possess an expert knowledge on equipment selection criteria for Filling Lines with RABS and Isolators, Lyophilizer, Formulation Systems etc.
• Should understand General process requirements of pharmaceutical / Life Science Pharmaceutical production facilities for Sterile Products.
• Ability and the initiative learn new types of facilities as required by clients requirements.
• Should possess an expert knowledge on Disposable Technology & latest GMP Trends. Should be able to guide the team in GMP reviews
• Exposure of simulation software’s such as HYSYS, ASPEN, Super Pro & Schedule Pro will be an added advantage
  
  
  

People and Team

• Fluency in English writing, speech, and comprehension.
• Strong communications skills
• Strong negotiation skills for getting client approvals.
• Strong presentation skills
• Develop working relationships across various disciplines.
• Supports internal learning and development / knowledge sharing in area of expertise within Jacobs
  
  
  

At Jacobs we value people. Having the right balance of belonging, career and lifestyle enables us to consistently deliver and exceed clients’ expectations.

Working alongside industry leaders, you will have the opportunity to develop your career working on key projects in an environment which encourages collaboration, knowledge sharing and innovation. To support your professional growth, Jacobs flexible working arrangements, extended leave options and a host of social, health and wellbeing events and initiatives will underpin our commitment to you.

At Jacobs it’s all about what you do, not where you are, which counts!

We value collaboration and believe that in-person interactions are crucial for both our culture and client delivery. We empower employees with our hybrid working policy, allowing them to split their work week between Jacobs offices/projects and remote locations enabling them to deliver their best work.

Your application experience is important to us, and we’re keen to adapt to make every interaction even better. If you require further support or reasonable adjustments with regards to the recruitment process (for example, you require the application form in a different format), please contact the team via Careers Support.