Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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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.

Summary Of Role

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)

Key Responsibilities

Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
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.
Mentoring junior staff and supporting them through their projects
Acting as Author and Reviewer of documents on behalf of the Validation Project Team on the introduction of new equipment
Be a team player, continue to drive good practice across the site, and continually improve the validation system.
Promoting and sustaining a working environment aligned with PCI Pharma Services ethos and procedures
Support all Regulatory Inspections, Customer visits and Customer audits on validation related queries as required.
Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Planning & Organising: Able to plan activities and tasks

Knowledge / Skills & Experience

Essential:

Bachelor’s or associate degree or Diploma / Certificate in Validation / Technical Engineering or Science based subject May substitute experience in lieu of educational requirements.
3-5yrs years’ experience working in Equipment Validation
QMS system experience necessary
Proven track record of showing how results were delivered through project management
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.)
Some travel required for business requirements
Customer facing experience
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
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
Decision Making: Identify and understand issues, problems and opportunities whilst providing
Strong insight into Pharma/Medical Device guidelines relating to regulatory and quality requirements

Desirable:

Prior experience with packaging equipment/processes - secondary packaging / blister packaging and high speed / automated lines would be a distinctive advantage for this position.
Experience in a GMP or Regulated Environment.
Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.

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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.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Sr. Validation Specialist

Job Description