Manager of Validation

Department: Validation

Job Title: Manager of Validation

Reports To: Plant Manager

1. Role Purpose:

This position is a member of the site leadership team and will manage the site commissioning and qualification, equipment qualification, and process and assay validation by ensuring the timely development, execution and coordination of all validation activities pertaining to facility, equipment and process in compliance with Quality System requirements, site procedures and regulatory requirements.  This role will develop validation and Quality System documentation (e.g., IQ/OQ/PQ/SOP/Change Controls/Deviations/CAPAs etc.). This role will organize and schedule all validation activities ensuring project completion per schedule requirements.

2. Key Duties & Responsibilities:

• Manage and Direct the Validation Staff

• Guide, mentor and counselor validation staff    

• Assure all validation work is compliant with regulatory guidance

• Assist with the training of the equipment operators

• Maintain the Company’s compliance with established Penn Life Sciences Standard Operating Procedures and specifications and Current Good Manufacturing Practices.

• Write, execute and coordinate commissioning, qualification and validation protocol testing.

• Schedule the execution of protocols

• Compile relevant commissioning/qualification/validation study data and generate summary reports to document the results of the studies.

• Aid in troubleshooting/impact assessment for atypical conditions during studies/ validations.

• Assist in the maintenance and development of any existing validation programs to ensure continued compliance with regulatory requirements.

• Provide scientific rationale/strategy for studies of new or modified GMP equipment and processes.

• Ensure all aspects of validation and qualification adhere to site and corporate policies and procedures, including safety and training.

• Review all errors, protocol deviations, and comments with the respective user department Management and QA and resolve discrepancies.

• Manage responsibilities and workload to assure accurate and timely data and reports.

• Complete any associated work order documentation.

• Review completed validation for accuracy and GMP compliance.

• Comply with FDA guidelines, Site and Corporate Policies for Data Integrity.

• Other duties as assigned.

3. Typical Supervisory Responsibility:

This position will be responsible for managing and directing all validation activities relating to equipment, facility, systems and processes at Penn Life Sciences. This position will direct the work flow for the Validation Department. It will assume a leadership role at the site; and will be required to effectively interact with all other departments within the site.

4. Education & Experience:

• Bachelor’s Degree preferred
• 3-5 years of validation work experience in a GMP environment, including sterile, project management experience preferred

5. Technical competencies/ Certifications/ Licenses:

• Ability to manage, supervise and plan multiple projects.

• Possess a working knowledge of Microsoft Word, Windows, Excel, Power Point, and Statistical tools such as Minitab/GMP

• Must possess excellent analytical skills, good problem-solving technique and data analysis skills using Excel.

• Employee must have excellent communication skills, both written and verbal

• Employee must be collaborative when working with groups.

• Attention to detail is required.

• Technical discipline (sciences, engineering) or related field

• Familiarity with Part 11 complaint electronic Quality Systems is preferred

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A