PCI Pharma Services · 8 hours ago
Quality Validation Engineer
Rockford, IL
Full-time
Onsite
Mid Level
$97K/yr - $107K/yr
3+ years expPCI Pharma Services is focused on the qualification and validation of pharmaceutical equipment and processes. The Validation Engineer will manage validation projects, generate and execute protocols, and ensure compliance with regulatory standards while interfacing with various internal and external stakeholders.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Hiring Manager
Shaniece Williams
Responsibilities
Write, review, and/or execute validation documentation (e.g., Installation/Operation/Performance/Test Method Qualification protocols, parameter pages, statements, risk assessments) for the assembly, inspection, testing, and packaging of medical devices to assure compliance with regulatory, internal, and customer requirements
Ensure efficient validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals in a timely manner as required
Serve as the primary validation representative for medical device packaging and assembly. Conduct and/or participate in customer conference calls, customer/regulatory audits and inspections, and face-to-face meetings
Interact with Sales, Project Management, Engineering, Maintenance, Production, Technical Services, Quality Assurance, and external customers to determine requirements for new projects
Effectively communicate project goals and progress to internal/external clients. Investigate deviations, document in formal reports, and assure resolution of corrective action to complete the validation
Participate in the change management process, outline requirements for validation through impact assessments, and prepare change control and validation history reports for audits
Review and approve pre-validation documents including, but not limited to, User Requirement/Acceptance Testing, Factory/Site Acceptance Testing, Engineering Studies, and batch records/packaging instructions
Apply engineering and statistical principles, theories, and techniques proficiently to support the validation of equipment, processes, and test methods for medical device assembly, inspection, testing, and packaging
Measure characteristics of medical devices (e.g, force, time, weight, length) and apply statistical methods (e.g., Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, Cluster Analysis, One-Way Analysis of Variance (ANOVA)) for determining and evaluating acceptance criteria
Support the validation of new technology/instrumentation with a focus on Data Integrity principles
May participate and/or assist in conducting Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify new equipment
Will be required to complete and pass GDP and GMP training courses
This position may require overtime and/or weekend work
Attendance to work is an essential function of this position
This position may require extra hours and/or weekend work
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules, and requirements
Performs other duties as assigned by Manager/Supervisor
Qualification
Required
Bachelor's Degree in a related field and/or 4-5 years of related experience and/or training
Must have a minimum of at least three years of experience in an FDA-regulated industry with a strong preference for medical devices or combination products
MUST HAVE experience with the development and execution of validation protocols in the pharmaceutical and/or medical device industry
Statistical and Advanced Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and know various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables
Ability to work on multiple projects at the same time
Ability to meet aggressive timelines
Good interpersonal/teamwork skills
Effective communication skills (verbal and written form)
Good documentation practice
Proficient in the use of computer software - Microsoft (Windows, Word, Excel, Outlook, PowerPoint), Minitab Statistical Software, and SPC software
Preferred
Ability to effectively present information to various people as the job requires
Ability to identify and resolve problems promptly
Ability to display original thinking and creativity
Ability to show success in managing employees
Ability to demonstrate attention to detail
Ability to set and achieve challenging goals
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