Validation Analyst 1
PCI Pharma Services
Summary
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.
Job description
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.
Requirements
- 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.
- 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.
Benefits
- Paid time off
- Health insurance
- Dental insurance
- Vision insurance
- Flexible spending account
- 401(k)
- Performance bonus
Company overview
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.