Manager, Validation 1st Shift

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

• Manage the development and writing of validation policies, procedures and protocols in validation program.

• Manage the IQ/OQ/PQ, cleaning and utilities validation. Work closely with Engineering on new equipment specifications and engineering changes as related to process and cleaning validation.

• Evaluate, identify and develop current company validation standards to meet global requirements and current industry standards.

• Manage, coordinate and provide QA oversight for assembling and issuing New Product Technical releases prior to initial release of product to the market.

• Manage, coordinate and provide QA oversight for line/ship tests and the calibration.

• Participate in training and instruction of departmental personnel and provide technical leadership

to the department.

• Provide technical support and assessment for processes, validation activities and investigations.

• Provide DOE (design of experiments) as needed for process, engineering studies and

investigations.

• Perform other related duties as required.

• Perform FATs as needed and provide technical expertise for acceptance test on site

• Other duties as assigned

QUALIFICATIONS:

• Requires the knowledge gained through a BS degree in Math, Science, Engineering or related

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

track record.

• Five years supervisory experience necessary in Validation and/or Technical Services.

• In-depth knowledge of current industry validation practices is required.

ACCOUNTABILITY:

Director, Quality or Acting