Validation Manager

5 months ago

Allentown, United States Sharp Corporation Full time
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. Position will be located at designated Allentown or Conshohocken site.

The duties of this position directly impact 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.

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 on a monthly basis 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.
  • Familiar 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. ANSI ZI.4) is required.
  • Ability to multi-task is required.
  • Ability to independently plan and schedule validation activities.
  • Proven ability to commit to and meet project deadlines is required.
  • Good written and oral communication skills are required.
  • Good organizational and planning skills are required.
MATHEMATICAL SKILLS:

Basic math skills (addition, subtraction, multiplication and division) are required. Ability to apply complex mathematical operations, scientific notation, and conversion factors. Advanced understanding of statistics including, but not limited to standard deviation, regression, distribution analysis, capability analysis, trend analysis, sampling theory, and Design of Experiments (DOE).

LANGUAGE SKILLS:

Ability to read, analyze, and interpret common scientific data and technical documents is required. Ability to read and interpret engineering documents and drawings is required. Ability to respond professionally to common inquiries or complaints from customers, regulatory agencies, or members of the business community regarding validation issues is required.
  • 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 Directors, Account Executives and 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.


WRITTEN SKILLS:

Ability to compile technically sound and grammatically corrective validation protocols and summary reports is required. Ability to produce clear and concise validation plans and/or memos to file in conformance with basic Good Documentation practices is required. Technical writing skills are required.

REASONING ABILITY:

Ongoing contact with internal Operations, Sales, Engineering and Quality Department employees, Customer QA representatives, occasional contact with regulatory personnel concerning compliance with customer requirements as well as cGMP's concerning validation issues. Customer agreements and regulatory guidelines are available to assist, however frequent review and reasonable interpretation are necessary to keep current. Good organizational skills are necessary. Good mental skills for analysis and problem solving are needed. Need an ability to negotiate to reach a common solution meeting everyone's need.

COMPUTERS SKILLS:

Must be proficient in Microsoft Office, Windows O/S , Pilgrim SmartSolve, Lotus Notes and related software applications.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands to handle or write and to speak and hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor and to work in close proximately to packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions.

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

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