Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main purpose of job:
Leading and managing all aspects of validation engineering within PCI’s commissioning and qualification of equipment and processes for critical projects.

Main responsibilities:

• Ownership and accountability for the progress and status updates of large-scale validation projects.
• Representation of project status, risks, and concerns to stakeholders and customers from a validation/quality perspective.
• Ensuring delivery of projects with an emphasis on quality from design to validation, focusing on Right First Time (RFT) and On Time In Full (OTIF) principles.
• Introducing new, compliant, and efficient equipment; including drafting User Requirement Specifications (URS), Functional Specifications (FS), Design review documentation, software, and hardware specifications (SDS and HDS), Standard Operating Procedures (SOPs), change controls, factory acceptance test (FAT), site acceptance test (SAT) protocols and reports, Validation Project Plan (VPP), Validation Summary Report (VSR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Validation (PV) protocols and reports. All other validation and quality documentation as required.
• Mentoring junior staff and supporting the onboarding of new team members.
• Planning and executing Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), coordinating with cross-functional teams.
• Ensuring timely completion of technical documentation in support of project schedules for new equipment introductions.
• Working cross-functionally to define line layouts using Good Engineering Practice (GEP).
• Supporting risk management processes, including risk assessment for new or modified equipment and processes.
• Acting as author, reviewer and approver on behalf of the validation department in the Validation process for new equipment introductions and NPI.
• Assisting in technical, product, and process reviews in conjunction with Operations to resolve issues.
• Ensuring all activities comply with statutory, regulatory, and company EHS, cGMP, and technical standards and procedures.
• Promoting and sustaining a working environment aligned with PCI Pharma Services Values and Behaviours.
• Collaborating across PCI Pharma Services to drive performance and consistency across sites.
• Managing specific or ad hoc projects / tasks as required to meet department and business needs.

LI-VR1

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status

• Ownership and accountability for the progress and status updates of large-scale validation projects.
• Representation of project status, risks, and concerns to stakeholders and customers from a validation/quality perspective.
• Ensuring delivery of projects with an emphasis on quality from design to validation, focusing on Right First Time (RFT) and On Time In Full (OTIF) principles.
• Introducing new, compliant, and efficient equipment; including drafting User Requirement Specifications (URS), Functional Specifications (FS), Design review documentation, software, and hardware specifications (SDS and HDS), Standard Operating Procedures (SOPs), change controls, factory acceptance test (FAT), site acceptance test (SAT) protocols and reports, Validation Project Plan (VPP), Validation Summary Report (VSR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Validation (PV) protocols and reports. All other validation and quality documentation as required.
• Mentoring junior staff and supporting the onboarding of new team members.
• Planning and executing Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), coordinating with cross-functional teams.
• Ensuring timely completion of technical documentation in support of project schedules for new equipment introductions.
• Working cross-functionally to define line layouts using Good Engineering Practice (GEP).
• Supporting risk management processes, including risk assessment for new or modified equipment and processes.
• Acting as author, reviewer and approver on behalf of the validation department in the Validation process for new equipment introductions and NPI.
• Assisting in technical, product, and process reviews in conjunction with Operations to resolve issues.
• Ensuring all activities comply with statutory, regulatory, and company EHS, cGMP, and technical standards and procedures.
• Promoting and sustaining a working environment aligned with PCI Pharma Services Values and Behaviours.
• Collaborating across PCI Pharma Services to drive performance and consistency across sites.
• Managing specific or ad hoc projects / tasks as required to meet department and business needs