PCI Pharma Services Validation Engineer in Rockford, Illinois
Life 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 Engineer is responsible for overall validation project ownership of high through low-risk project(s) under limited to no supervision. Responsible for generation and execution of validation protocols, assistance in audits, determination of validation needs, and training of Analysts. 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 ensure compliance with government and customer requirements.
Prepares and executes validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, reports, summaries, and master validation plans for new customer/product/system project launch and maintains existing validated processes and coordinating internal and customer approvals, as needed.
Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
Assist in the Change Control process, and prepare change control and validation history reports for audits.
Attends conference calls and meetings.
Effectively communicates project goals and progress to Supervisor / Manager. Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project.
Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.
Review and approve User Requirement Specifications, Functional Specifications, and Engineering Study Protocols Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment Harmonization/streamlining of validation activities Coordinate validation efforts with mechanics, operators, and engineering Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.
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.
Performs other duties assigned. High-risk projects” are generally defined as projects/customer accounts that have the following.
Business needs of customers/projects may require considerable time commitments.
High level of uncertainty in managing customer expectations.
Have a validation approach with significantly more or more complex requirements in addition to the Validation Master Plan.
May or may not have established criteria, which may be subject to interpretation.
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 essential functions.
Bachelor's Degree in a related field and/or 1-3 years of related experience and/or training.
College Level Mathematical Skills
Experience with the development and execution of validation protocols for process, equipment, cleaning, and computer systems in the pharmaceutical and/or medical device industry
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 practices
Proficient in the use of computer software - Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Access, SPC software, and Microsoft PowerPoint
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
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/Facilities Validation Focus: Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and a high understanding of heating, air conditioning, and refrigeration systems.
Computer Validation Focus: Ability to perform highly complex computer tasks and have experience with computer systems considered to have an impact on cGMP, cGMP, Annex 11, and PCI guidelines.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
PCI Pharma Services
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