Validation Analyst 2

Validation Analyst II

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.

The Validation Analyst II is responsible for overall validation project ownership of moderate risk project(s) under mild supervision. Responsible for the generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities.

Essential Duties and Responsibilities :

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned :

• Performs validation activities to ensure compliance with government and customer requirements.
• Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer / product / system project launch and maintains existing validated processes / programs at multiple sites, as well as organizing and coordinating internal and customer approvals, as needed.
• Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
• Prepares change control and validation history report for audits.
• Attends conference calls and meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager.
• Investigate validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project.
• Primary contact for quality validation activities and managing expectations.
• Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.
• Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11, and Annex 11 policies, procedures, rules, and requirements.
• Required to complete and pass a "Documentation Boot Camp" course within 6 months.
• This position may require overtime and / or weekend work.
• Attendance at work is an essential function of this position.
• Performs other duties as assigned.

Moderate Risk Projects are generally defined as projects / customer accounts that have the following :

After basic training, this position will be required to specialize in 1 or more Validation areas of focus :

Qualifications :

The requirements listed below are representative of the knowledge, skills, and / or abilities required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Required :

Preferred :

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.