Process Engineer-Hybrid

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:

The Process Engineer is responsible for introducing new processes and/or products (product transfer). The Process Engineer will develop and transfer knowledge of Lean Six Sigma Change Management and Inclusion. Steer and/or participate in cross-functional investigations on problems/deviations-including defining corrective and preventive actions. Identify analyze and prioritize technical or business related processes improvement-opportunities and problems. Initiate and coordinate improvements for technical or business processes systems and behaviors. Contribute to a data driven decision making process Ensure effective application of Lean Six Sigma and Change Management tools by leading projects facilitating kaizens and coaching sponsors and practitioners. Ensures manufacturing operations are continually supported and maintained in compliance with all quality safety and environmental regulations. Position will receive direction and support.

Requirements

Responsibilities:

• Coordinate execute & document qualification & process studies and additional product programs where applicable.
  
• Respond to operational and business areas ensuring compliance with cGMP & regulatory requirements
  
• Accountable for compliance via documentation completion risk assessments closing out corrective actions participation in audits and inspections and proactively highlighting any issues around compliance
  
• Generation review and approval of process documentation.
  
• Execution of development and qualification studies across commercial and non-commercial product.
  
• Representing Technical Operations department at cross functional meetings.
  
• Development and qualification of new processes.
  
• Qualification of new equipment where appropriate.
  
• Lead & support investigations and troubleshooting of process studies as required.
  
• Technical support for commercial manufacturing.
  
• Technical support for new product introduction.
  
• Ensure compliance with the QMS industry/company specific standards and regulations.
  
• Demonstrate effective communication and interpersonal skills.
  
• Proactively act to consistently improve personal knowledge and capability.
  
• Demonstrate an awareness of own capabilities and development needs.
  
• Lead & support continuous improvement by active participation in and contribution to projects and problem-solving including use of MPS processes and tools.
  
• Application of technical knowledge to enable authoring of technical documents and technical decision making.
  
• Support audit readiness including preparation of story boards ensuring GMP compliant documents are available presentation to auditors as required.
  
• Work collaboratively to drive a safe and compliant culture
  
• Participate in driving a high performing & inclusive culture stimulating personal growth & development.
  
• May be required to perform other duties as assigned.
  
• Accountable for contribution to ensure that objectives are effectively achieved consistent & regulatory requirements.
  
• Respond to Operational and business areas ensuring compliance with cGMP requirements
  
• Support continuous improvement by active participation in and contribution to projects and problem- solving including use of MPS processes and tools.
  
• Ensure that adequate processes and procedures are in place and followed for all relevant process activities.
  
• Support business critical projects related to the Technical Operations department.
  
• Provide technical support for cross functional programs & investigations
  
• During the first month of the contract the role will require a predominantly onsite presence to support onboarding and initial collaboration. Following this period the role will transition to a hybrid work model with onsite attendance generally expected 23 days per week subject to business requirements.
  
• Bachelors Degree or higher preferred; ideally in a Science Engineering or other Technical discipline