Validation Analyst 2

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 II is responsible for overall validation project ownership of moderate-risk projects (s) under mild supervision. Responsible for the generation and execution of validation protocols, assistance in audits, and the determination of 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 ensure compliance with government and customer requirements.
• Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer/product/system project launches and maintains existing validated processes/programs at multiple sites, as well as organizing and coordinating internal and customer approvals, as needed.
• Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.
• Prepares change control and validation history report for audits.
• Attends conference calls and meetings. Effectively communicates project goals and progress to the Validation Supervisor / Manager.
• Investigate validation deviations, document in formal reports, and ensure resolution of corrective action to complete a project.
• Primary contact for quality validation activities and managing expectations.
• Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.
• Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11, and Annex 11 policies, procedures, rules, and requirements.
• Required to complete and pass a "Documentation Boot Camp" course within 6 months.
• This position may require overtime and/or weekend work.
• Attendance at work is an essential function of this position.
• Performs other duties as assigned.
• Moderate Risk Projects are generally defined as projects/customer accounts that have the following:

  Moderate level of uncertainty in managing customer expectations.

  Validation approach with moderately complex requirements in addition to the Validation Plan.

  Established criteria that are subject to some interpretation.

  Business needs of the customer/project may require additional time commitments.

• After basic training, this position will be required to specialize in 1 or more Validation areas of focus:

• a. Process/Cleaning Validations
• b. HVAC/Utility Validations
• c. Computer Validations

Qualifications: The requirements listed below are representative of the knowledge, skills, and/or abilities required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• High School Diploma or GED and/or 3-5 years related experience and/or training.
• College-Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and have knowledge of various 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:

• 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 Validation Focus: Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems.
• Computer Validation Focus: Associate degree in a related field and/or 1-3 years related experience and/or training.
• Ability to perform complex computer tasks and have some experience with computer systems is considered to have an impact on cGMP, cGXP, Annex 11, and PCI guidelines.

For candidates in Illinois: The hiring rate for this position is $22.15-$24.92 hourly, 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).

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.