Validation Manager

SUMMARY

Responsible for supervision of Validation staff and coordination validation activities at designated site.  Responsible for design, scheduling, preparation, execution and completion of assigned validation projects.  Guides Validation Engineers in the development of validation test scripts.  Areas of responsibility include all validation projects related to IQ/OQ/PQ/PV of packaging equipment, cleaning validation and utilities qualification.  The position will be located at designated Allentown or Conshohocken site.

The duties of this position directly impact company compliance with 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.

• Manage the validation program at the assigned site.
• Responsible for creating, reviewing, revising and approving documents with cGMP impact that include standard operating procedures, work instructions, test methods, validation and equipment qualification packages.  Represent the Validation function in the review and approval of Change Controls involving equipment and processes.
• Develop validation requirements for projects related to new equipment, processes, and facilities.
• Responsible for developing and documenting Product Master Validation Plans and for communicating validation approach and requirements with customers.
• Coordinate preparation and execution of validation protocols and reports in support of project schedule.
• Responsible for communicating validation approach and requirements with customers.
• Responsible for supervising the execution and summarization of validation activities at designated Sharp facility including but not limited to packaging, cleaning, HVAC and computer system.  Guide validation engineers in development of new test scripts as required.
• Develop, maintain and improve key measures metrics for all areas of responsibility.  Publish metrics monthly to support department and Management Review requirements.
• Develop staff to support smooth succession and compliance with all U.S. Food and Drug Administration (FDA) requirements.  Responsible for review and development of Job Description’s for all subordinate staff.
• Design and implement proficiency training for all areas of responsibility.   Coordinate training plans must be appropriately interfaced with Sharp Compliance requirements.
• Participate in customer or regulatory audits at Sharp facilities as required.
• Follow-up on all audits specific to the site including assisting in the audit response and monitoring commitments specific to the related issues.
• Investigate or oversee investigations for non-conformances related to execution of validation protocols.
• Support the investigation of consumer complaints specific to related areas.

SUPERVISORY RESPONSIBILITIES:

Direct supervision of Validation teams at assigned site.  Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.  Responsibilities include interviewing, hiring, training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE:

Bachelor’s degree in technical discipline (BS/BA) from a four-year college or university preferred with five 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 desired.

• 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.
• Familiarity with quality variable and attribute sampling plans (e.g. AN