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Responsible for overall validation project ownership of limited risk project(s) under heavy supervision. Responsible for generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities.

• Performs validation activities to assure compliance to government and customer requirements.
• Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer / product / system project launch 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 Validation Supervisor / Manager.
• Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete 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 to work is an essential function of this position.
• Performs other duties as assigned.
• “Limited Risk Projects” are generally defined as projects/customer accounts that have the following.
• Business needs of customer/project require standard time commitments.
• Low level of uncertainty in managing customer expectations.
• Standard validation approach as documented in the Validation Plan.
• Established criteria that are subject to minimal interpretation.
• After basic training, this position will be required to specialize in 1 or more Validation areas of focus:
• Process/Cleaning Validations
• HVAC/Utility Validations
• Computer Validations

Special Demands:

• Stationary Position: From 1/2 to 3/4 of the day.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: From 1/2 to 3/4 of the day.

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:

• 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: Ability to perform complex computer tasks and have some experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11, and PCI guidelines.