Validation Analyst 2

RiseMe; Illinois; On-site; USD 31,000 - 34,000; Full time

Benefits offered by this job

Paid time off

Health insurance (including dental and

Vision coverage

Flexible spending account

401(k) plan

Job summary

PCI Pharma Services is seeking a Validation Analyst II to manage validation projects across sites, coordinating protocols, change controls, and audit readiness. The role focuses on ensuring compliance with government and customer requirements and delivering quality validation deliverables.

Ideal candidates will have a high school diploma or GED with 3–5 years of related experience, strong math skills, and solid communication. Some overtime may be required; a training boot camp is mandatory.

Qualifications

• High School Diploma or GED and/or 3-5 years related experience and/or training.
• College level mathematical skills.
• Intermediate computer skills with ability to perform more complex tasks.
• Minimum professional proficiency for clear communication in varied contexts.
• Intermediate reasoning to apply instructions and solve problems.

Responsibilities

• Performs validation activities to assure compliance to government and customer requirements.
• Prepares validation protocols, validation statements, and master validation plans for new projects and maintaining existing validated processes.
• Ensures validation package documentation completion and closure including internal and external approvals.
• Prepares change control and validation history reports for customer audits.
• Attends conference calls and meetings and communicates progress to Validation Supervisor/Manager.
• Investigates validation deviations and documents corrective actions to close out.
• Manages customer expectations for quality validation activities.
• Reviews standards and specifications for dissemination relative to validation protocols.
• Reviews production jacket and issuance to ensure internal standards are met.
• Adheres to PCI, cGMP, GCP, GAMP, 21CFR, and Annex 11 policies and requirements.
• Passes and completes a Documentation Boot Camp course.
• Overtime and/or weekend work may be required.
• Attendance to work is an essential function.
• Performs other duties as assigned.

Skills

College Level Mathematical Skills

Intermediate Computer Skills

Minimum Professional Proficiency

Intermediate Reasoning

Education

High School Diploma or GED and/or 3-5 years related experience and/or training

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.

#LI-SW1

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.

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.