PCI Pharma Services ยท 5 months ago
Validation Analyst 2
USA_IL_18th Avenue
Full-time
Onsite
Mid Level
$22.15/hr - $24.92/hr
3+ years expPCI Pharma Services is a company dedicated to making an impact in the biopharma industry. They are seeking a Validation Analyst II who will be responsible for the overall validation project ownership of moderate risk projects, including the generation and execution of validation protocols and ensuring compliance with regulations.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Performs validation activities to ensure compliance with 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 the Validation Supervisor / Manager
Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the 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 at work is an essential function of this position
Performs other duties as assigned
'Moderate Risk Projects' are generally defined as projects/customer accounts that have the following: Business needs of the customer/project may require additional time commitments. Moderate level of uncertainty in managing customer expectations. Validation approach with moderately complex requirements in addition to the Validation Plan. Established criteria that are subject to some 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 3-5 years related experience and/or training
College-Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and know various 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
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: Associate's Degree in a related field and/or 1-3 years related experience and/or training. 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)
A 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