RFD_Validation Analyst 3

PCI TRGR Penn Pharmaceutical Services Ltd; Rockford (IL); Hybrid; USD 37,000 - 43,000; Full time

Benefits offered by this job

Paid time off

Health insurance (including dental and

Vision coverage)

401(k) plan

Flexible spending account

Job summary

PCI is hiring a Validation Analyst III in Rockford, IL. The role focuses on managing validation projects for major customers, drafting protocols and validation plans, and coordinating with teams and clients to meet regulatory standards.

The position emphasizes accurate documentation, audit support, and timely issue resolution, with additional responsibilities as needed. A 2nd shift with 10% premium is noted in the posting.

Qualifications

• Associate degree or related experience required; college math skills essential.
• Proficiency with business software and data handling tasks.
• Fluent English, strong problem solving and communication abilities.
• Ability to present information clearly to diverse audiences.

Responsibilities

• Manage validation projects for large customer accounts with minimal supervision.
• Prepare validation protocols, statements, and master plans for launches.
• Coordinate internal and customer approvals and audit support.
• Investigate deviations and document CAPAs to close validation activities.
• Communicate progress to Validation Supervisor/Manager and customers.

Skills

Math skills

Computer skills

English fluency

Reasoning skills

Presentation skills

Education

Associate degree

Job description

## RFD\\_Validation Analyst 3Apply: Rockford, IL, USA: Full time: Posted Today: JR119825Life 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:** 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:*** 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.