RFD_Validation Analyst 3

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; Vor Ort; USD 37.000 - 43.000; Vollzeit

Benefits dieser Stelle

Paid time off

Health insurance (including dental and

Vision

401(k) plan

Zusammenfassung

PCI Pharma Services is seeking a Validation Analyst III for the 2nd shift, offering an additional 10% shift premium. The role oversees validation project management for large customer accounts, prepares protocols and validation plans, and coordinates approvals across multiple sites to ensure quality and compliance.

You will support customer audits and drive corrective actions when deviations occur. The position requires an Associate's Degree with 1–3 years of related experience, strong

Qualifikationen

• Associate's Degree in a related field and/or 1–3 years related experience.
• Strong mathematical and analytical abilities.
• Proficient in computer applications and software tools.
• Excellent written and verbal communication; ability to work under minimal supervision.

Aufgaben

• Manage validation activities to meet government and customer requirements.
• Prepare validation protocols, statements, and master validation plans for new launches and maintain existing validated processes across sites.
• Coordinate internal and customer approvals and document closure of validation packages.
• Attend customer meetings and effectively communicate goals and progress to leadership.
• Investigate deviations and document corrective actions to complete projects.
• Serve as customer contact for quality validation activities and manage expectations.
• Review standards and specifications to ensure alignment with validation protocols.
• Ensure production documents meet internal standards and procedures.

Kenntnisse

Math skills

Computer proficiency

Oral and written communication

Problem solving

Follow instructions

Time management

Decision making

Audit readiness

Ausbildung

Associate's Degree in related field

Tools

None

Jobbeschreibung

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.

2nd Shift: Additional 10% Shift Premium

Summary of Objective

The Validation Analyst III is responsible for overall validation project management of large customer accounts under minimal supervision. Responsible for generation and execution of validation protocols, assistance in customer audits, and determination of customer validation needs. 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.
• 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.

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 the essential functions.

Required

• Associate's Degree in a related field and/or 1-3 years related experience and/or training.

Other Qualifications

• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• 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.
• Preferred Ability to effectively present information to various people as the job requires.
• Ability to follow instructions and respond to management direction.
• Ability to identify and resolve problems in a timely manner.
• Ability to display a willingness to make decisions.
• Ability to display excellent time management skills.
• Ability to set and achieve challenging goals.

Salary

The hiring rate for this position is $27.27-$30.68 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise.

Benefits

• PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

#LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

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.