PCI Pharma Services · 11 hours ago
Validation Analyst 1
Rockford, IL
Full-time
Onsite
Entry Level
$19.96/hr - $22.46/hr
1+ years expPCI Pharma Services is dedicated to creating life-changing therapies with a global impact. The Validation Analyst I will manage validation projects, generate and execute validation protocols, and assist in customer audits under supervision.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
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
Qualification
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
Benefits
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k)
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase