Validation Analyst 1

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; On-site; USD 27,000 - 31,000; Full time

Benefits offered by this job

Paid time off

Health insurance coverage (including d

Flexible spending account

401(k)

Job summary

PCI Pharma Services in Illinois seeks a Validation Analyst I to manage validation projects for small customer accounts under close supervision. You will generate and execute validation protocols, support customer audits, and determine validation needs across projects.

This role requires adherence to cGMP, GAMP, 21 CFR Part 11, and related standards, with attention to detail and the ability to communicate progress to managers and customers.

Qualifications

• High School Diploma or GED, 1–3 years related experience or training.
• Basic Math skills required.
• Ability to perform basic computer tasks and operate common computer programs.
• Ability to participate effectively in conversations (professional proficiency).
• Ability to read standard items addressed to general readers.
• Ability to apply common sense to carry out instructions and handle problems.

Responsibilities

• Performs validation activities to ensure compliance with government and customer requirements.
• Prepares validation protocols, statements, and master validation plans for new launches and maintains existing validated processes across sites.
• Ensures validation documentation is complete and properly approved.
• Prepares change control and validation history reports for audits.
• Communicates project goals and progress to the Validation Supervisor/Manager.
• Investigates deviations and documents corrective actions to close projects.
• Acts as customer contact for validation activities and manages expectations.
• Interprets customer standards and specifications for validation protocols.
• Reviews production paperwork to ensure alignment with internal standards and procedures.
• Adheres to PCI, cGMP, GCP, GAMP, 21 CFR Part 11 and Annex 11.

Skills

Basic Math

Computer literacy

Communication

Attention to detail

Teamwork

Independent work

Education

High School Diploma or GED

Job description

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 Analyst I is responsible for overall validation project management of small customer account(s) under heavy 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

• 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

• 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.
• Preferred: Ability to demonstrate attention to detail.
• Ability to work independently and/or part of a team.
• Ability to follow instructions and respond to management direction.
• Ability to adapt to changing work environments.
• Ability to display a willingness to make decisions.
• Ability to effectively communicate information to various people as the job requires.

The hiring rate for this position is $19.96 -$22.46 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.

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

• paid time off
• health insurance coverage (including dental and vision)
• flexible spending account
• 401(k)

#LI-DT1 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.