Validation Analyst 2

PCI Pharma Services; Winnebago Court (IL); On-site; USD 31,000 - 34,000; Full time

Benefits offered by this job

Paid time off

Health insurance (dental & vision)

Flexible spending account

401(k) plan

Job summary

PCI Pharma Services in the United States seeks a Validation Analyst II to oversee validation project management for intermediate customer accounts under moderate supervision. You will generate and execute validation protocols, assist in customer audits, and determine customer validation needs.

The role emphasizes coordination across multiple sites, handling change controls, and ensuring compliance with 21 CFR Part 11 and cGMP policies. Weekend overtime may be required.

Qualifications

• High School Diploma or GED with 3–5 years related experience.
• Proficiency with mathematical concepts and data analysis.
• Experience with multiple computer programs and intermediate computer skills.
• Ability to participate effectively in conversations and read standard items.

Responsibilities

• Manage validation activities to meet government and customer requirements.
• Prepare validation protocols, statements, and master plans across sites.
• Coordinate internal and customer approvals and change controls.
• Prepare validation history reports for customer audits.
• Attend meetings and report progress to the Validation Supervisor/Manager.
• Investigate deviations and implement corrective actions.
• Interface with customers on quality validation activities and expectations.
• Review standards and specifications for validation protocols.

Skills

Mathematical skills

Computer skills

Professional communication

Reasoning

Education

High School Diploma or GED

College level mathematical skills

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 of Objective:

The Validation Analyst II is responsible for overall validation project management of intermediate customer accounts under moderate supervision. Responsible for generation and execution of validation protocols, assistance in customer audits, and determination of customer 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 assure compliance to government and customer requirements.
• Prepares validation protocols, validation statements, and master validation plans for new customer / product / system project launch and maintaining existing validated processes / programs at multiple sites as well as organizing and coordinating internal and customer approvals as needed.
• Ensures validation package documentation completion, accuracy, and closure including organizing and coordinating internal and customer approvals.
• Prepares change control and validation history report for customer audits.
• Attends conference calls and customer meetings and effectively communicates project goals and progress to Validation Supervisor / Manager.
• Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete project.
• Customer contact for quality validations activities and manage customer expectations.
• Reviews and interprets customer standards, procedures and specifications for dissemination relative to process and cleaning validation protocols.
• Reviews production jacket and issuance to ensure that documents meet internal requirements for standards and procedures.
• Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.
• Required to pass and complete a "Documentation Boot Camp" course.
• This position may require overtime and/or weekend work.
• Attendance to work is an essential function of this position
• Performs other duties as assigned.

Qualifications:

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

Required:

• High School Diploma or GED and/or 3-5 years related experience and/or training.
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various 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

• Ability to effectively present information to various people as the job requires.
• Ability to follow instructions and respond to management direction.
• Ability to identify and resolve problems in a timely manner.
• Ability to display a willingness to make decisions. Ability to display excellent time management skills.
• Ability to set and achieve challenging goals.

The hiring rate for this position is $22.15-$24.92 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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

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.