Validation Analyst 3-1

PCI TRGR Penn Pharmaceutical Services Ltd; Illinois; On-site; USD 38,000 - 42,000; Full time

Benefits offered by this job

Paid time off

Health insurance (dental and vision)

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services is seeking a Validation Analyst III to lead validation projects across multiple sites, ensuring compliance with government and customer requirements. You will prepare validation protocols, statements and master plans, and coordinate internal and customer approvals for new and existing processes.

The role requires an Associate's Degree with 1–3 years related experience, strong math and computer skills, and the ability to communicate effectively with customers and teams.

Qualifications

• Associate's Degree in a related field. 1–3 years related experience and/or training.
• College level mathematical skills and ability to perform complex tasks.
• Full professional proficiency: speak, read, and write fluently for professional needs.
• Strong problem solving and time management abilities.

Responsibilities

• Performs validation activities to assure compliance to government and customer requirements.
• Prepares validation protocols, validation statements, and master validation plans.
• Maintains validation documentation and coordinates internal and customer approvals.
• Attends conference calls and customer meetings to communicate progress.
• Investigates deviations and documents corrective actions to complete projects.
• Reviews standards and specifications for dissemination to validation protocols.
• Ensures production documents meet internal standards and procedures.

Skills

Math skills

Computer skills

Communication

Education

Associate's Degree in related field

Tools

Office Suite

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 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. The essential duties and responsibilities include the following but other duties may be assigned.

• 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.

Qualifications

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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

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.

Hiring Rate and Benefits

The hiring rate for this position is $27.27-$30.68 per hour plus eligibility for an annual performance bonus. 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.

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.