Senior Manufacturing 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.

Summary:

• The role involves utilizing project management best
  practices for the effective and efficient development of savings type projects
  on the Value Capture Program.
  
• The incumbent will also utilize Engineering principles
  and Lean problem -solving skills to improve and maintain products/processes that
  are aligned with the overall Quality and Business vision of site goals on
  reducing Scrap, Consumables usage, Direct Labour wastage. He/she will be tasked
  at the identify, scope, design and lead several projects.
  
• 12 Month of contract role
  

Requirements

Responsibilities:

• Team member representing the End 2 End Engineering
  function supporting projects with a focus on Quality, Savings, Capacity,
  Validation type projects used in the manufacturing processes across the entire
  Orthopaedic Range of Products
  
• Prepare several documents on the projects & dash;
  scoping, designing, implementation & execution
  
• Support colleagues to complete several project related
  tasks
  
• Responsible for identifying savings on site linked to
  Direct Labour in -efficiencies, Scrap, Consumables spend.
  
• Ensuring new or amended manufacturing process
  improvements are aligned with operation's needs, quality, EHS, validation,
  finance, automation, maintenance requirements, seeking collaboration and
  funding for the project with Senior Leaders.
  
• Presentation to Senior Management Weekly on Status or
  need for funding
  
• Determine operations & process inputs and outputs
  ranges of machine prior to commencing validation
  
• Responsible for conducting (where appropriate)
  Installation, Operating and Performance Qualification (IQ, OQ, PQ) of assets
  and associated machines.
  
• Partner with Quality, Operations, CSV and other cross
  functional partners to ensure the correct application of design controls, risk
  management and the investigation/correction of design Communicate effectively
  with project manager and other managers, global functions and internal team on
  status of project (s) tasks, issues and requirements.
  
• Provide timely and accurate reporting and management of
  escalations as appropriate on project activities.
  
• Ensure all activities comply with GMP, ISO and quality
  system requirements.
  
• Ensure that all health, safety and environmental
  requirements are fulfilled.
  

Education & Experience Required:

Essential:

• MSc in Engineering or Science with > 7
  years’ experience in a medium to high volume manufacturing
  environment – Food Processing, Paint Industry, Oil & Gas,
  Orthopedics
  2 year in a similar capacity in a regulated industry
  (i.e. FDA/ISO)
  Work from the office to hands on with fellow
  Engineer’s development of trials, experiments, development of
  projects.
  

Desirable:

• Experience working in both an FDA and European regulatory
  environment is preferred with an in -depth knowledge of 21 CFR 820, CFR 11 and
  European regulations associated with the medical device industry.
  
• A thorough understanding of GMP/ISO and validation
  regulations.
  
• Technical training Six Sigma/Black Belt/Lean
  Manufacturing experience projects using Statistics, Lean and Six Sigma
  Methodologies is preferred including Measurement System Analysis, SPC, DOEs,
  Reliability, etc.
  
• Problem solving engineering expertise (Six Sigma, SE or
  A3)
  
• Understanding of the Mechanical Engineering process and
  Process Validation expertise is preferred
  
• Strong verbal and written communication skills
  

Reports To: Project Leader