Validation Analyst 1

PCI TRGR Penn Pharmaceutical Services Ltd; Rockford (IL); On-site; USD 27,552 - 30,307; Full time

Benefits offered by this job

Paid time off

Health insurance (Dental & Vision)

Flexible spending account

401(k)

Job summary

PCI is seeking a Validation Analyst I to manage validation projects with supervision, developing and executing protocols, and assisting with customer audits. The role involves coordinating validation activities, preparing documentation, and ensuring compliance across sites in a high-regulation environment.

The candidate should have a High School Diploma or GED with 1–3 years related experience, basic math and computer skills, and strong attention to detail.

Qualifications

• Basic mathematical skills required.
• Basic computer skills and ability to perform basic tasks.
• Minimum professional proficiency: able to participate in conversations and read standard items.
• Intermediate reasoning: apply common sense to instructions and problems.
• Attention to detail is preferred.

Responsibilities

• Perform validation activities to ensure compliance with government and customer requirements.
• Prepare validation protocols, validation statements, and master validation plans for new and existing projects across multiple sites.
• Organize and coordinate internal and customer approvals and ensure documentation accuracy and closure.
• Prepare change control and validation history reports for customer audits.
• Attend calls and meetings, effectively communicate goals and progress to supervisor/manager.
• Investigate deviations and document corrective actions to complete projects.
• Serve as customer contact for quality validations and manage expectations.

Skills

Basic Math

Basic Computer Skills

Professional Proficiency

Reasoning

Attention to detail

Education

High School Diploma or GED

Job description

## Validation Analyst 1Applylocations: Rockford, IL, USAtime type: Full timeposted on: Posted Todayjob requisition id: JR118834Life 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 I is responsible for overall validation project management of small customer account(s) under heavy 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 1-3 years related experience and/or training.* Basic Mathematical Skills* Basic Computer Skills: Ability to perform basic computer tasks and has the ability to 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:*** Ability to demonstrate attention to detail.* Ability to work independently and/or part of a team.* Ability to follow instructions and respond to management direction.* Ability to adapt to changing work environments.* Ability to display a willingness to make decisions.* Ability to effectively communicate information to various people as the job requires.The hiring rate for this position is $19.96 -$22.46 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), flexible spending account, and 401(k).