“Coating Place is an established pharmaceutical contract manufacturer specializing in Wurster fluid bed processing and delivery system development. We provide our customers with modified and extended release bulk active products through innovative development and manufacturing capabilities with an integrated quality philosophy.”

• Assist with establishing, reviewing, executing, and ensuring compliance with regulatory requirement, policies, and procedures related to validation activities.
• Utilize tools for conducting and executing validations and provide direction to assure components possess the necessary level of testing and required documentation to comply with applicable GxP regulations and client requirements/expectations.
• Coordinate and maintain compliance through the requalification program.
• Prepare validation and test strategies for validation initiatives and work with project teams to identify test requirements and advise on the design of the testing phases.
• Advise on/be involved in the performance of application, functionality, usability, and acceptance testing.
• Ensure that all necessary validation documentation is produced and reviewed for correctness, completeness, and clarity.
• Writes and reviews relevant SOPs.
• Assists in updates/revisions to the Validation Master Plans.
• Perform Quality Investigations, as required.
• Provides guidance in acceptance testing and identifying company needs.
• Supports and reviews equipment calibration and data packages/documents, as needed.
• Follows all CPI safety practices, policies, and procedures.
• Other duties as assigned.

• Bachelor’s Degree in Engineering (or equivalent science related field)
• 2-5 years previous pharmaceutical experience supporting manufacturing, analytical, and validation activities, including equipment, process, computer, and utilities.
• Demonstrated knowledge of cGMPs, FDA, and other regulatory agency requirements.
• Demonstrated technical knowledge and understanding of facilities, equipment, and quality systems within a pharmaceutical setting
• Proficiency in Microsoft Office required
• Ability to communicate both verbally and in writing across all levels of the organization, internally and externally.
• Ability to maintain effective working relationships in order to effectively negotiate and solve problems.
• Excellent organizational and multi-tasking skills.
• Ability to handle multiple projects and project management.
• Sound practical judgment of priorities and high attention to detail.
• A continuous improvement and quality mindset.
• A willingness to develop themselves and others within the department.