Technical Engineer-Hybrid

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, 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 points 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 through Learning & Development in-house training mentorship with constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client's expectations regarding quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

• This Technical Engineering role will play a key part in the development of the client site drug product facility.
  
• This role is to lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction. This includes but is not limited to: Tech Transfer, Validation programs & strategies, Technical support, and process improvement projects, network support & collaboration.
  
• The Technical Engineering role will collaborate across functions, supporting, coaching, and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable standards for Quality and EHS compliance.
  

Responsibilities:

Safety:

• Work collaboratively to drive a safe and compliant culture. Collaborate with multiple partners (e.g., network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programs.
  
• Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering at Global Technical Forums as required.
  

Compliance:

• Required to comply with Global Policies, Procedures and Guidelines,
  
• regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  
• Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections, and proactively highlight any issues around compliance.
  

Process Engineering & Validation:

• To lead and execute process engineering and validation activities to support the technical transfers.
  

Projects:

• To lead and manage multiple Technical Engineering projects needed to support the business. This includes but is not limited to: Process improvements, capital projects, and Lean projects across multi-disciplined functions which may also require global and network support and collaboration.
  
• Responsibility to lead an integrated project team in delivering the project business case and collaborating closely with cross-functional teams to establish scope in improvement projects as we ramp up to a fully commercial site.
  
• To manage and deliver on all technical/Validation/Quality Notification/Change control/Project support within the technical engineering team. Use scientific, product, and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting.
  
• Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g., Structured Root Cause Analysis, Statistical Process Control, Data-driven decision making).
  
• Drive collaboration between group functions and proactively look for synergies and innovative ways of doing work. Constantly assess our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.
  

Technical Expertise:

• Act as a subject matter expert on (1) Equipment Design (2) Assisting in C&Q execution and planning; (3) Process design and validation.
  
• Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects. May be required to perform other duties as assigned.
  

Qualifications, Skills and Education Required:

General:

• Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers/scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage.
  
• Proven track record in delivering results in a world-class supply organization.
  
• A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment.
  
• Innovative thinker, with excellent decision-making and problem-solving skills.
  
• Experience of working in a cross-functional environment.
  
• Knowledge of and experience in applying Six Sigma and Lean methodologies.
  
• Positive, flexible action-oriented attitude.
  

Technical:

• Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  
• In-depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing.
  
• Experience of executing and/or managing through equipment and process validation in a sterile environment.
  
• Knowledge of QbD/CPV desirable.
  
• Excellent report, standards, policy writing skills required.
  
• Automation and MES knowledge.
  
• Proficiency in Microsoft Office and job-related computer applications required.
  
• Experience in audit preparation and execution desired.
  
• Having a strong safety ethos.
  
• Strong Data Analysis capability.
  
• Have proven record of process improvement implementation.
  
• Proven record in planning and basic project management of a team to deliver on time/schedule and cost.
  

People:

• The passion to expand the future.
  
• Ability to participate in highly effective teams.
  
• The desire to continuously learn, improve and develop.
  
• A great communicator, decisive decision-maker with a proven ability to deliver excellence.
  
• Strong leadership and interpersonal skills.
  
• Willingness to support the team and a strong focus on delivering excellence.
  
• High personal integrity, credibility, energy, and flexibility.
  
• Strive to be innovative in how we do business.
  
• Engage with our business colleagues and learn from them as well as from our own experiences.
  
• Self-motivated and flexible approach.
  
• Effective time management and multi-tasking skills.
  
• Excellent attention to detail.
  
• Goal/results orientated.
  
• Demonstrable analytical and systematic problem-solving skills.
  

Education:

• Degree qualification or equivalent (Science, Engineering, Technical).
  
• Green Belt preferable.
  

Reporting to: Technical Engineering Lead