PCI Pharma Services · 1 day ago
Validation Analyst 1
Rockford, IL, USA
Full-time
Onsite
Entry Level
$19.96/hr - $22.46/hr
1+ years expPCI Pharma Services is a company focused on providing life-changing therapies with a global impact. The Validation Analyst I will manage validation projects under supervision, generate and execute validation protocols, and assist in customer audits to ensure compliance with regulations.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Performs validation activities to assure compliance to government and customer requirements
Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer / product / system project launch and maintains existing validated processes / programs at multiple sites as well as organizing and coordinating internal and customer approvals, as needed
Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required
Prepares change control and validation history report for audits
Attends conference calls and meetings. 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
Primary contact for quality validation activities and managing expectations
Reviews and interprets standards, procedures and specifications for dissemination relative to validation protocols
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements
Required to complete and pass a “Documentation Boot Camp” course within 6 months
This position may require overtime and/or weekend work
Attendance to work is an essential function of this position
Performs other duties as assigned
“Limited Risk Projects” are generally defined as projects/customer accounts that have the following
+ Business needs of customer/project require standard time commitments
+ Low level of uncertainty in managing customer expectations
+ Standard validation approach as documented in the Validation Plan
+ Established criteria that are subject to minimal interpretation
After basic training, this position will be required to specialize in 1 or more Validation areas of focus:
+ Process/Cleaning Validations
+ HVAC/Utility Validations
+ Computer Validations
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
Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements
Required to complete and pass a 'Documentation Boot Camp' course within 6 months
Attendance to work is an essential function of this position
Preferred
Process/Cleaning Validation Focus: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active packaging operation
HVAC/Utility Validation Focus: Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems
Computer Validation Focus: Ability to perform complex computer tasks and have some experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11 and PCI guidelines
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