Process 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
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:

Responsible for generating and expediting review and
approval processes for IPT GMP documentation including but not limited to
Quality Notifications, CAPA close out records, IPT Standard Operating
Procedures and Standard Work Instructions and change controls. Ensure that
objectives are effectively achieved, consistent with requirements to ensure
compliance, safety and reliable supply to our customers.

Requirements

Accountabilities:

• Support manufacturing activities through documentation
  generation, equipment and process investigations associated with non -GMP
  activities and completion of quality notifications. Provide input to the MES
  development process team on technical aspects of MES functionality and serve as
  MES SME within IPT
  
• Be a document system expert; this will include document
  review, approval and document system work flow expedition. Format, write,
  deliver and review necessary documentation in line with the standard approval
  process, and facilitate others to do so. Documents will include SOP’s, SWI’s,
  training documents, and change controls. Support operation activities through
  documentation generation, filing, tracking, auditing and efficient maintenance
  of all associated databases including the maintenance, auditing and archiving
  of the process documentation system.
  
• Support Batch release through timely Quality Notification
  completion, Interim/summary report generation; meeting batch release
  requirements.
  
• Raise CAPA's and conduct investigations. Raise and
  investigate quality notifications using standard tools and methods, to resolve
  system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent
  corrective action through the change management system.
  
• Complete Customer complaint investigations and Change
  Controls and ensure they are closed out to support production activities in a
  timely manner in conjunction with the SCM team.
  
• 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.
  
• Work collaboratively to drive a safe and compliant
  culture
  
• May be required to perform other duties as assigned.
  
• Assist in the management and/or assignment of IPT
  training if required
  

Skills and Knowledge:

Typical Minimum Education:

• Bachelor’s Degree or higher preferred; ideally in a
  Science, Engineering or other Technical discipline
  

Typical Minimum Experience:

• Relevant experience and a particular skill set in their
  area of expertise that adds value to the business; ideally in a manufacturing,
  preferably GMP setting
  

Core Competences:

Technical:

• SAP knowledge and experience required
  
• Proficiency in Microsoft Office and job related computer
  applications required
  
• Knowledge of regulatory/code requirements to Irish,
  European and International Codes, Standards and Practices
  
• Report, standards, policy writing skills required
  
• Equipment and process validation
  
• Sterile filling processes and equipment
  
• Lean Six Sigma Methodology experience desired
  

Business:

• Excellent communication, presentation and interpersonal
  skills, to interface effectively with levels of colleagues and with external
  customers in a team orientated manner
  
• Understand the specific responsibilities of all departments
  as they relate to ones department, understanding the business processes ones
  department supports
  
• Strong team skills, including ability to coach/develop
  work teams
  
• Excellent training, facilitation and assessment skills
  
• Risk management skills
  
• Strategy planning and development
  
• Demonstrable analytical and systematic problem solving
  skills
  
• Strong influencing skills
  
• Flexible approach
  
• Effective time management and multi -tasking skills
  
• Proven organizational skills
  
• Excellent attention to detail
  
• Trouble shooting skills
  
• Goal/results orientated
  

Leadership:

• Focus on Customers and Patients
  
• Collaborate
  
• Act with Candor and Courage
  
• Make Rapid, Disciplined Decisions
  
• Drive Results
  
• Build Talent
  
• Demonstrate Ethics and Integrity
  

Reports to: Operations Coach (Manufacturing Support)