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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.
SUMMARY
The Validation Analyst I is responsible for the qualification of pharmaceutical packaging equipment, processes, cleaning, facilities/utilities, and/or computer systems. Core functions include management of multiple limited risk validation projects, generation and execution of validation protocols, direct interface with internal/external customers/regulatory agencies, and determination of customer validation needs. Requires the ability to work with other departments to define, prioritize, schedule and complete validation projects such that PCI’s internal/external compliance standards and production targets are achieved. Occasional overtime/weekend work is required.
NOTE: Employees who have received a counseling report for a violation occurring within the last 3 months are not eligible to apply for open positions
DUTIES AND RESPONSIBILITIES
1. Limited Risk Validation Projects
2. Serve as the primary validation representative for assigned projects. Conduct and/or participate in customer conference calls, customer/regulatory audits and inspections, and face-to-face meetings.
3. Interact with Sales, Project Management, Engineering, Maintenance, Production, Facilities, Information Technology, Quality Assurance, and external customers to determine requirements for new projects.
4. Review pre-validation documents including, but not limited to, User Requirement/Acceptance Testing, Factory/Site Acceptance Testing, Engineering Studies, and batch records/packaging instructions.
5. Prepare Validation documents including, but not limited to, protocols, parameter pages, statements, risk assessments, room/warehouse layouts, final summary reports, and periodic/product reviews.
6. Test equipment and systems for adherence to validation protocols and summarize results.
7. Conduct discrepancy investigations to identify root cause and corrective/preventive actions.
8. Knowledge of and adherence to all cGMP, regulatory, and global policies, procedures, and requirements.
9. Other documentation, assignments, and/or projects as assigned by management.
After basic training, the Validation Analyst will be trained in 1 or more of the following specializations.
1. Equipment Validation Specialization
2. Process/Cleaning Validation Specialization
EQUAL OPPORTUNITY EMPLOYER/DISABLED/VETERANS
Join us and be part of building the bridge between life changing therapies and patients.
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.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.