Sharp Services

Responsible for independent planning, coordination and execution of validation activities either on-site (within Sharp facility) or off-site (supplier or client facility). Responsibilities include execution of all validation activities related to equipment, process, facilities and computer systems as required. Validation activities will be performed at all facilities within the guidelines of current good manufacturing practices. Responsible for ongoing contact with Operations, Sales, Engineering, Quality Assurance, and customers regarding validation activities and scheduling.

Scope of the position includes both Conshohocken and Allentown facilities. The position will be located at one designated site.

The duties of this position directly impact on company compliance to regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities related to this position. Other duties may be assigned.

Support the Validation Manager in the development of validation approach, design and execution.

Represent the Validation function in the review and approval of Change Controls involving equipment and processes.

Complete the Validation review and approval of Sharp Master production Records.

Develop validation requirements for projects related to new equipment, processes, facilities and products.

Write IQ/OQ/PQ protocols for appropriate equipment and systems within the guidelines of cGMP.

Responsible for supervising the execution of validation activities at designated Sharp facility including but not limited to packaging, cleaning, HVAC and computer system.

Write PV protocols specific to customer needs.

Responsible for communicating validation approach and requirements with customers.

Monitor or execute validation protocols assigned.

Review executed protocols and write final reports.

Responsible for supervising the execution of validation activities at designated Sharp facility including but not limited to packaging, cleaning, HVAC and computer system.

Participate in customer audits specific to validation activity at all Sharp facilities at the direction of the Validation Manager.

Participate in external regulatory audits specific to validation activities at the direction of the Validation Manager

SUPERVISORY RESPONSIBILITIES:

Moderate including scheduling, daily checks of project status, and supporting Validation Manager as requested. Oversee project team members and support Validation staff in the development and execution of protocols and reports. Review executed protocols for conformance with requirements and good validation practices.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree in technical discipline (BS/BA) from a four-year college or university preferred with six to ten years related experience and or training; or equivalent combination of education and experience. Independent certification of advanced quality skills and practices (i.e. ASQ, CQE, Six Sigma, etc.) is required

• Broad knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents is required.
• Familiarity with quality engineering practices in manufacturing operations is required.
• Knowledge of basic engineering principles and practices, equipment automation controls, etc. is required.
• Ability to independently plan and schedule validation activities is required.
• Ability to structure validation protocols in conformance with a planned validation approach is required.

Ability to effectively present information to the following groups:

• Internal: daily contact with Quality Department, Sales, Engineering and Operations Department employees for information exchange, collaboration, problem solving, direction regarding customer validation issues. Frequent contact with Account Executives and/or Project Managers for information exchange and direction regarding customer validation issues.
• External: Frequent contact with customer representatives planning new product introductions, and problem-solving validation issues. Occasional contact with client auditors and regulatory representatives (e.g. FDA, DEA) for inspections, questions and problem resolution related to validation matters as required by the Validation Manger.

Approximately 10 percent travel between Sharp sites and to off-site assignments.

Travel to customers and to equipment suppliers on an as needed basis.