Validation Cleaning Specialist

AMRI   •  

Albuquerque, NM

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 60 days ago

This job is no longer available.

Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

Summary:


The Cleaning Validation Principal is an essential part of the Validation department. The Cleaning Validation Principal will be responsible for completing validation activities including those that relate to cleaning; as well as review applicable change controls and maintenance and revision of the essential validation documents including the Equipment Cleaning Validation Master Plan and the Facility Cleaning Validation Master Plan.

The Cleaning Validation Principal will work with other departments to make sure the cleaning validation activities associated with new products are performed according to established schedules, user requirements and needs. This position is also responsible for managing the cleaning validation activities of the validation department during shutdown activities and ensuring the plant is in a ready state to manufacture product after shutdown activities have been completed.

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Essential Duties and Responsibilities include the following.

  • Ensures change controls, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP).
  • Coordinates validations with section supervisors to ensure timeliness with minimal disruption of production schedules.
  • Reviews and writes cleaning validation protocols, final reports, and summaries of work for release of products tested.
  • Serves as cleaning validation liaison between the site and customers or regulatory agencies during facility audits.
  • Supports departmental strategic goals to assure the highest quality standards and regulatory compliance.
  • Other duties as assigned.

Job Requirements

Education and/or Experience

(Minimum required to perform job)

Advanced degree in Science/Applicable degree and 3 years relevant experience.

BS in Science/Applicable degree and 7 years relevant experience.

HS Diploma, some college coursework in applicable curriculum and 15 years relevant experience.

(Minimum required to perform job)

A minimum of 3 years of progressively greater responsibilities in the pharmaceutical/medical devices industry, including project, technical, and personnel management. Prefer 3 to 4 years in an aseptic/ sterile product facility.

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills

To perform this job successfully, an individual should have knowledge of Database software; Manufacturing software; Spreadsheet software and Word Processing software.

Other Skills and Abilities

Provide review and approval for qualification, validation, re-qualification, and re-validation documents for equipment and cleaning process protocols and final report.

  • Writes equipment cleaning validation master plan and facility cleaning validation master plan.
  • Writes and approves validation protocols for process validations and cleaning validations, and provides similar support for computer related systems and environment monitoring.
  • Manages, executes and works with department stakeholders to complete cleaning/equipment validation protocols.
  • Provides audit support by presenting cleaning validation activities to customers and regulatory agencies.
  • Supports new product introduction activities as they relate to product categories, cleaning, the product-specific Quality Risk Management Plan (QRMP) and the site QRMP.
  • Reviews and revises SOP's as needed for approval.
  • Directly understand and implement safety procedures and cGMP.
  • Provide information to customers on validation activities (e.g., cleaning, etc.) and improvement plans, as needed.