Validation Manager
Alkermes, Inc. - Gainesville, GA

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The Validation Manager is primarily responsible for site validation activities to include equipment, product, process and cleaning validation and reporting of activities utilizing the corporate, business unit and site policy and procedures. With minimal direction, the Validation Manager will run the day to day operations and manage the areas of responsibility to assure effective and timely response to the validation needs of the organization.

Major Duties/Responsibilities
  • Manage, train, counsel and mentor the validation staff. Develop group goals and assist staff in implementing these goals.
  • Maintain a high level of understanding of relevant pharmaceutical regulations and current interpretations affecting equipment, product, process and cleaning validation.
  • Develop a strategy for performing validation projects. Manage the validation activities to assure that validation projects are scheduled and performed as needed.
  • Participates in developing and managing the department budget.
  • Particpates in Regulatory and Client Audits on all validation related queries.
  • Evaluates the outcomes of all validations (equipment, product, process and cleaning) and, as appropriate, develop action plans/corrective actions with the impacted department. Participates in the approval or disapproval of vendors for use as it pertains to the validatability of the equipment / service.
  • Manage outside consultants in support of validation activities.
  • Manage the site’s risk assessment program.
  • Consult with various people inside and outside of the company.
  • Maintain the validation schedule. Prepare reports as required.
Minimum Job Qualifications

Education Bachelor’s degree in Mechanical, Chemical, Electrical or related Engineering field. Other science based degrees will be considered based on experience.

Experience
  • Five (5) to eight (8) years related experience in the pharmaceutical and/or medical device industry with 2-5 years direct experience with process, equipment, and/or cleaning validation.
  • Experience with cGMP, environmental regulatory requirements, and new validation guidelines.
  • Three (3) years leadership experience (supervisory/management/project management)

Special Training Lean/Six Sigma training preferred

Skills/Abilities
  • Strong analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
  • Proven project management skills
  • Strong computer skills and knowledge of word processing software and spreadsheet software
  • Competent in leading technical projects
  • Competent in pharmaceutical compliance and regulatory policies
  • Knowledge of pharmaceutical industry guidelines, trends and practices
  • Act with professionalism and treat others with respect and consideration regardless of their status or position

Travel

Up to 5%

Physical and Mental Demands and Work Environment

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

Physical Demands

While performing the duties of this job, the employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and ability to adjust focus.

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl. .

Mental Demands

While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management contractors, vendors and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; collate and interpret technical and engineering data; generate technical reports of investigations; analyze and solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; establish priorities and work on multiple assignments and projects concurrently.

The employee is regularly required to apply computer skills covering word processing, spreadsheet and presentation software.

The employee is regularly required to apply mathematical formulae and engineering rules of thumb to tasks and execute technical and engineering calculations.

Work Environment

In certain assignments, the employee will occasionally work outdoors; work near moving mechanical parts; work in high, precarious places; work near fumes or airborne particles and chemicals, which may require the employee to wear specified Personal Protective Equipment. .

The noise level in the work environment is usually moderate to loud

Alkermes, Inc. - 22 months ago - save job