RFD_Validation Analyst 3

RiseMe; Illinois; On-site; USD 38,000 - 42,000; Full time

Benefits offered by this job

Shift premium 10%

Annual bonus opportunity

Full benefits package

Job summary

PCI Pharma Services is seeking a Validation Analyst III to lead validation project management for large customer accounts. The role involves generating and executing validation protocols, assisting in customer audits, and coordinating with internal and external stakeholders across multiple sites.

Required are an Associate's Degree with 1-3 years of related experience, strong mathematical and computer skills, and professional fluency.

Qualifications

• Associate's Degree in a related field and/or 1-3 years related experience.
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Speak, read, and write fluently and accurately on professional needs.
• High Reasoning: Solve practical problems with limited standardization.

Responsibilities

• 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 launches.
• Ensures validation package documentation completion, accuracy, and closure including approvals.
• Prepares change control and validation history report for customer audits.
• Attends conference calls and customer meetings and communicates progress to Validation Supervisor/Manager.
• Investigates deviations and ensures corrective action to complete projects.
• Reviews standards and specifications for dissemination to process and cleaning validation protocols.
• Reviews production jacket and issuance to ensure documents meet internal standards.
• Adheres to PCI, cGMP, GCP, GAMP, 21CFR and Annex 11 policies and completes required training.

Skills

Mathematics ability

Intermediate computer skills

Professional fluency

Strong reasoning

Education

Associate's Degree

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.

2nd Shift

Additional 10% Shift Premium

Summary of Objective

The Validation Analyst III is responsible for overall validation project management of large customer accounts under minimal 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

• 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

• Associate's Degree in a related field and/or 1-3 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.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

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 $27.27-$30.68 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.

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.