MS&T Technology Transfer 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 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.

Profile:

Our Engineers help ensure that internal and external manufacturing operations remain operational continuously improve and innovate. With our extensive range of facilities and environments our Engineers have opportunities across many diverse areas including Biological Chemical Automation Capital Projects Maintenance Safety Process Development Technical Services Utilities and Validation.

The Manufacturing Science and Technology (MS&T) Drug Product Technical Operations (DS Tech Ops) organization is seeking a highly motivated individual for a Technology Transfer position. DP Tech Ops is accountable for technology transfers and commercial production of finished Drug Product. This person will have the opportunity to participate in all areas of Tech Ops. This may include supporting the execution of technology transfers providing manufacturing process support to resolve commercial production issues and to provide support for process and capacity optimization.

Requirements

Responsibilities include:

• Work with Internal Partners to achieve business goals.
  
• Provide support within the Drug Product manufacturing team including areas such as Formulation Filling Lyophilisation Capping and Automated Visual Inspection.
  
• Responsible for process ownership demonstrating technical excellence as the subject matter expert (SME) for drug product processes
  
• Responsible for technical activities for the commercial manufacturing process which includes authorship of change control management of process improvement projects statistical analysis of process performance and investigation of atypical events.
  
• Responsible for technology transfer activities as applicable through authorship and/or review of required GMP documentation (Master Batch Records change control protocols reports qualifications etc.) and regulatory filings.
  
• Provide on-site coverage in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
  
• Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations and Quality
  
• Ensure that Site is inspection ready for all routine inspections and / or inspections related to new product introductions or transfers in concert with Operations Quality and Regulatory.
  
• Responsible for participation in creating sharing and adopting best practices and business process strategies.
  

Education Minimum Requirement:

• Bachelors degree in Chemical/Biochemical Engineering Pharmaceutical Science or Chemistry/Biology or other related science or engineering field.
  

Required Experience and Skills:

• Minimum of 3 years post-bachelors degree experience in a GMP functional area or support of a GMP functional area such as Operations Technical Operations Technology Engineering and/or Maintenance
  
• Strong communication in English and teamwork skills
  

Preferred Experience and Skills:

• Proven expertise in aseptic operations analytical testing process development and tech transfer.
  
• Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirable
  
• Experience with lyophilized products advantageous
  
• Experience in start-up facility advantageous
  
• Demonstrated ability to independently manage projects/work to schedule/deadlines
  
• Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
  
• Experience in deviation management and/or change control and/or equipment support and/or equipment qualification and/or project management.