Formulation Engineer-Drug Product

About PSC Biotech

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, pharmaceutical contract manufacturing professionals, and metrology services to our clients.

Employees are the “heartbeat” of PSC Biotech. We provide unparalleled empowering career development through in-house training, mentorship, and 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.

• Provide technical leadership within a new Vaccine Drug Product Manufacturing facility.
• Ensure all equipment installed is safe, effective and in compliance with industry standards.
• Ensure all company and site engineering policies and procedures are adhered to.
• Provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs.
• Generate and execute documentation for cGMP activities including risk assessments /reports.
• Management of Equipment Vendors including execution of on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments.
• Support/lead maintenance of the validated state of the equipment through execution of revalidation protocols as per Site VMP.
• Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Manage changes to equipment/process as per site change control procedures.
• Support establishment of new Preventative Maintenance Program for equipment in Drug Product suite.
• Lead/participate in equipment related manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis & impact analysis is completed and appropriate CAPAs are implemented.
• Identify process and equipment improvements and develop these into CI projects.
• Support disposition of batches by addressing any potential technical / engineering related issues which may have occurred mid-batch.
• Lead/participate in, TPM, CI & Gemba programs and daily / weekly tiered manufacturing meetings.
• Provide technical expertise during regulatory inspections e.g. FDA, HPRA inspections to defend systems, change controls, investigations and qualification packages.
• Support transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processes.
• This is an 11 Month Contract role.

• Minimum 5 years cGMP industrial / engineering experience.
• Experience in executing on the floor activities such as FAT, SAT, IQ/OQ.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g. Six Sigma.
• Experience in leading & resolving complex technical investigations.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA.
• Ability to adapt to changing priorities as project demands change.

• Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.

• Specific experience with Autoclave, Parts Washers, and CIP/SIP equipment.
• Knowledge of Formulation processes.
• Experience in start-up facilities is advantageous.
• CQV experience is advantageous.
• Knowledge of industry/ regulatory requirements such as Annex 1 desirable.
• Ability to explain complex technical issues to external customers / agencies.
• Demonstrated excellence in planning and organizational skills.
• Demonstrated skills in communication (oral and written) & in particular technical writing.

Reporting to:
Engineering Lead

• Mid-Senior level

• Contract

• Engineering and Information Technology