Validation Supervisor

Location: North Carolina

POSITION SUMMARY

• Responsible for equipment, computer related system, cleaning and process validation protocol executions.
• Complete validations independently to ensure timeliness with minimal disruption of production schedules.
• Writes validation protocols, final reports and summaries of work for release of equipment or products tested.
• Responsible for supervising Validation Scientists, and Associate Validation Scientists; managing the staff to ensure, that the responsibilities and expectations of the department are met or exceeded.
• Responsible for ensuring that critical manufacturing equipment validations, including equipment computer related systems, cleaning and process validation protocols and procedures meet all regulatory requirements, as well as meet or exceed current pharmaceutical industry standards.
• Responsible for ensuring that all site validated systems are maintained in a validated state through re-qualification where applicable.
• Provide continuous support to the manufacturing and facilities departments to drive validation projects to successful completion, on time and within budget.

RESPONSIBILITIES

•  Participate and coordinate cross-functional teams responsible for the

execution of Validation projects.

•  Develop and evaluate validation master plans, sampling plans,

acceptance criteria and demonstrate process capability to ensure the

success of new products transfer and validation comply with site

procedures, to ensure that the supply of pharmaceuticals are in

compliance with corporate, client and regulatory requirements.

•  Schedules validations with area supervisors, ensuring timely completion

with minimal disruption of production schedule.

•  Assigns validation projects, re-qualifications, change control, and other

tasks to Associate Scientists and Scientists in accordance with senior

managements’ priorities.

•  Analyzes data and writes, and/or review final reports and summaries for

validation protocols with minimal supervision.

•  Develops and review changes to validation procedures.
•  Manage Validation projects for existing and new Capital investments –

deliver improvements to current project execution timeline and budget.

•  Lead critical investigation teams and manage and resolve Validation

issues arising throughout new project life cycles while ensuring the overall

project objectives of scope, cost and schedule are adhered to.

•  Champion the technical training rollout of Validation Standards at the site.
•  Conducts special projects as directed by management.
•  Demonstrate strong leadership, organizational, communication and time

management skills.

REQUIREMENTS

•  Minimum Bachelor Degree in Science or Engineering Field with 5-8 years

relevant experience.

•  Must be able to focus on computer terminals for extended periods of time.
•  Ability to clearly read and write English.
•  Ability to work effectively under pressure to meet established deadlines.
•  Ability to stand, sit for long periods of time, walk, drive and lift 0-25 lbs.
•  Specific vision requirements include reading or computer and written

documentation. Frequent use of computer is required along with the ability

to clearly see and focus on objects and color at close and far distances

with good depth perception.

• Must have the ability to wear a respirator for a period of time and meet

personnel gowning requirements for the Aseptic Area