Process Equipment Engineer

About PSC Biotech

Who we are?
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:

The Process Equipment Engineer will be a highly motivated individual who will work across a cross functional team (project and sustain) to implement appropriate maintenance strategies and technical training for the BioNX facility as it moves from project to sustain phases.

Responsibilities:

• The primary focus of this role is the implementation of preventative and corrective maintenance of GMP process equipment (Tangential Flow filtration skids, Chromatography skids, Viral inactivation skids, autoclaves, parts washers, bioreactors, and various biopharmaceutical equipment).
  
• Act as point of contact for Maintenance Systems. Support process equipment breakdowns and perform initial troubleshooting of issues.
  
• Deal with equipment vendors to set up the service level agreements to outline preventative maintenance support and breakdown support. Act as a point of contact between vendors, scheduling and manufacturing for equipment breakdowns.
  
• Support Site acceptance testing and qualification activities with primary focus on building SME level of knowledge of the process equipment to support the sustaining of process equipment in a Manufacturing environment.
  
• Represent the Maintenance Engineering group at cross functional team meetings for the project delivery.
  
• Support the handover of process equipment from project team to the sustaining manufacturing team.
  
• Support the reliability team with FMECA and criticality assessments of both instrumentation and GMP process equipment. Provide SME support to the building of any preventative maintenance tasks and spare parts list in the CMMS system (SAP)
  
• Own Process Hazards assessment (PHA) actions, support EHS risk assessments, contamination control strategies for process maintenance.
  
• Support Autoclave PQ activities and engineering batches.
  
• Draft SOP and Work instructions as required
  
• Lead and support equipment related deviations and appropriate corrective actions
  

Requirements

Experience, Knowledge and Skills:

Min 2-5 years experience in BioPharma industry

Experience with single use process system (process skids) and some hard piped systems (Autoclaves, parts washer, and buffer skid)

Good working knowledge of DeltaV, OSI PI (ability to build trends and troubleshoot)

Experience with SAP PM or equivalent CMMS system (Work order generation workstream and closure)

Managing 3^rd party vendors and ability to build relationships with various equipment manufactures.

Ability to data mine and statistical analysis for both troubleshooting and knowledge building purposes.

Qualifications:

The ideal candidate will have a Level 8 degree in Science, Engineering or Equivalent