Summary of Role:

The role of the Validation Specialist is to implement and execute tasks relating to Process, Facility and Equipment Development at PCI Pharma Services sites. 

Areas of validation included are:

Process Validation (PV)

Cleaning Validation (CV)

Computer Systems Validation (CSV)

Key Responsibilities:

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
• Ensuring all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
• Comply with Site Validation Master Plan.
• Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports. Also to generate and maintain documentation for cleaning validation performed at PCI sites in Ireland.
• Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
• Perform sampling in support of validation studies, including AQL, and cleaning validation.
• Manage tooling validations and associated documentation.
• Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
• Support complaint investigations, deviation investigations and change controls as required.
• To undertake such tasks and to manage specific or ad hoc projects as and when required to meet business needs and within the scope of the job-holder’s capabilities.
• Identify and support opportunities for improving processes and or procedures.
• Perform Periodic reviews and revalidations on a scheduled basis.
• Work with Validation team to ensure a robust and compliant validation system is in place. 
• Ensure validation being performed is in line with industry standards and latest regulatory guidelines. 
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.

Essential: 

• Bachelor’s or associate degree or Diploma / Certificate in Quality / Validation. May substitute experience in lieu of educational requirements. 
• Minimum 2 years’ experience working in Manufacturing or Quality.
• Demonstrate interest in Validation.
• Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets. 
• Ability to manage multiple tasks and set priorities.
• Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems. 
• Self-motivated with a results driven approach.
• Flexibility to work across different shifts on request in line with business needs.
• Adaptable and ability to work collaboratively.
• Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.).
• Experience in a GMP or Regulated Environment.

Desirable:

• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
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Summary of Role:

The role of the Validation Specialist is to implement and execute tasks relating to Process, Facility and Equipment Development at PCI Pharma Services sites. 

Areas of validation included are:

Process Validation (PV)

Cleaning Validation (CV)

Computer Systems Validation (CSV)

Key Responsibilities:

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
• Ensuring all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
• Comply with Site Validation Master Plan.
• Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports. Also to generate and maintain documentation for cleaning validation performed at PCI sites in Ireland.
• Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
• Perform sampling in support of validation studies, including AQL, and cleaning validation.
• Manage tooling validations and associated documentation.
• Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
• Support complaint investigations, deviation investigations and change controls as required.
• To undertake such tasks and to manage specific or ad hoc projects as and when required to meet business needs and within the scope of the job-holder’s capabilities.
• Identify and support opportunities for improving processes and or procedures.
• Perform Periodic reviews and revalidations on a scheduled basis.
• Work with Validation team to ensure a robust and compliant validation system is in place. 
• Ensure validation being performed is in line with industry standards and latest regulatory guidelines. 
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.

Essential: 

• Bachelor’s or associate degree or Diploma / Certificate in Quality / Validation. May substitute experience in lieu of educational requirements. 
• Minimum 2 years’ experience working in Manufacturing or Quality.
• Demonstrate interest in Validation.
• Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets. 
• Ability to manage multiple tasks and set priorities.
• Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems. 
• Self-motivated with a results driven approach.
• Flexibility to work across different shifts on request in line with business needs.
• Adaptable and ability to work collaboratively.
• Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.).
• Experience in a GMP or Regulated Environment.

Desirable:

• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.