Validation Analyst II

Overview

Join to apply for the Validation Analyst II role at PCI Pharma Services

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.

Responsibilities

• Own validation projects of moderate risk under mild supervision, including generation and execution of validation protocols and assistance in audits.
• Prepare validation protocols, validation statements, reports, summaries, and master validation plans for new customer / product / system launches; maintain validated processes / programs at multiple sites; organize and coordinate internal and customer approvals.
• Ensure validation documentation is complete, accurate, and properly closed, including coordinating multiple approvals as required.
• Prepare change control and validation history reports for audits.
• Attend conference calls and meetings; communicate project goals and progress to the Validation Supervisor / Manager.
• Investigate validation deviations, document in formal reports, and ensure timely resolution of corrective actions to complete the project.
• Serve as the primary contact for quality validation activities and managing expectations; review and interpret standards, procedures, and specifications for dissemination related to validation protocols.
• Maintain knowledge of and adherence to PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11, and Annex 11 policies and requirements.
• Complete and pass a "Documentation Boot Camp" course within 6 months; overtime and / or weekend work may be required; attendance at work is an essential function of the position.

Moderate Risk Projects are defined as projects with additional time commitments, moderate uncertainty in managing customer expectations, and validation approaches with moderately complex requirements beyond the Validation Plan. Established criteria may be subject to some interpretation. After basic training, specialize in 1 or more validation areas of focus.

S Computer Validations

Qualifications

The following represent the knowledge, skills, and abilities required for the stated position; reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Preferred

For candidates in Illinois : The hiring rate for this position is $22.15 to $24.92 hourly , plus eligibility for an annual performance bonus. Final offer amounts depend on experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a benefits package that includes paid time off, health insurance (including dental and vision), a flexible spending account, and a 401(k).

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future.

Equal Employment Opportunity

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 core to our purpose : Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by upholding the highest standards of understanding, fairness, respect, and equal opportunity at every level.

Additional Information

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

We are PCI.

Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Seniorities and employment types have been indicated where applicable.

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