Manager, Validation - 1st Shift (Lynchburg, VA)

TITLE : Manager, Validation - 1st Shift

DEPARTMENT : Quality

OCCUPATIONAL SUMMARY :

Manage the functions for validation of product and cleaning of in-house manufacturing and packaging systems. This includes commissioning, engineering studies, IQ / OQ / PQ, process validation and cleaning validation. Serve as management representing Validation during internal and external audits. Lead technical evaluation on process investigation and validation troubleshooting. Develop company validation standards that meet current industry standards for pharmaceuticals & train the key stakeholders.

Accountabilities

• Manage all company validation functions related to manufacturing, raw materials, packaging, testing, and distribution of our products, including writing protocols and final reports, reviewing testing methods, and analysis of data.
• Lead validation staff and resources provide training and coaching.
• Provide oversight, writing and execution of commissioning documents and Engineering studies and IQ / OQ / PQ, process validation and cleaning validation.
• Development and execution of a validation program that complies with industry standards and applicable government regulations.
• Provide technical assessment and support for validation and investigations and effectively develop & write risk assessments.
• Moderate direct impact on profitability results from maintaining proper adherence to validation and stability guidelines.

Responsibilities

to the department.

investigations.

QUALIFICATIONS :

field with a minimum of 7 years technical experience in pharmaceuticals industry with a proven

track record.

ACCOUNTABILITY :

Director, Quality or Acting

WHAT WE OFFER

Here at Fleet, you can have a good job that can grow into a great career.

No Sponsorship : Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.