Validation Analyst 1

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 Objective:

The Validation Analyst I is responsible for overall validation project ownership of limited risk project(s) under heavy 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 launches 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 reports for audits.
• Attends conference calls and meetings. Effectively communicates project goals and progress to Validation Supervisor / Manager.
• Investigate validation deviations, document in formal reports, and ensure 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.

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

a. Business needs of customers/projects require standard time commitments.

b. Low level of uncertainty in managing customer expectations.

c. Standard validation approach as documented in the Validation Plan.

d. Established criteria that are subject to minimal interpretation.

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

a. Process/Cleaning Validations

b. HVAC/Utility Validations

c. Computer Validations

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

Required:

• High School Diploma or GED and/or 1-3 years related experience and/or training.
• Basic Mathematical Skills
• Basic Computer Skills: Ability to perform basic computer tasks and operate common computer programs.
• Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
• Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form.
• Ability to deal with problems that involve several concrete variables in standardized situations.

Preferred:

• Process/Cleaning Validation Focus: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active packaging operation.
• HVAC/Utility Validation Focus: Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems.
• Computer Validation Focus: Ability to perform complex computer tasks and have some experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11, and PCI guidelines.

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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, Diversity, Equity, and Inclusion (DEI) 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.