Job description
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.
We are now looking for a Senior Validation Specialist to join our team in City North, Ireland.
Main purpose of job:
The role of the Validation Specialist is to implement and execute tasks relating to operational support for product launches (Projects), Process, Facility and Equipment Development at PCI Pharma Services sites. Areas of validation included are:
- Equipment Qualification
- Tooling Qualification
- Process Validation (PV)
- Cleaning Validation (CV)
- Computer Systems Validation (CSV)
Main responsibilities:
- Support the validation effort for all Strategic Projects on site.
- 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).
- Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
- Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner. Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence. Support change controls as required.
- Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
- Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
- Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions.
- Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis.
- Be a team player, continue to drive good practice across the site, and continually improve the validation system.
- Prior experience with packaging - secondary packaging / blister packaging and high speed / automated lines would be a distinctive advantage for this position.
- Support all Regulatory Inspections, Customer visits and Customer audits on validation related queries as required.
Personal Characteristics:
- Communication: Excellent communication and presentations skills, both written and oral – ability to present risk-based project validation strategy in a clear and concise manner to the Business Unit Planners, Customers and where required, to senior management
- Planning & Organising: Able to plan activities and tasks
- Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution
- Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints
- Passion for Results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients.
Let’s talk future
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.
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.
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