Benefits:

• 401(k)
• Competitive salary
• Dental insurance
• Health insurance
• Opportunity for advancement
• Paid time off

Job Description:
The Validation Manager, Validation will support Aseptic Simulation Studies performing for Sterile Products and Bio-similar products at the companies site. This role will be responsible for leading Aseptic Simulation studies from early planning, building strategies in a collaborative manner across internal disciplines and external partners and contractors.
This is an exclusive listing.
Essential Duties and Responsibilities:

• Design and develop the Aseptic Process Simulation (APS) program for Aseptic and Biosimilar injectables.
• Conduct risk assessments and mitigate risks associated with aseptic processing operations.
• Consider multiple factors in the design of APS studies including Bracketing / Definition of Simulations / Interventions, clean room

Staff qualification, Risk Base determination of Interventions, Microbiological Investigations and Environmental Monitoring as Part of the Media Fill, Incubation, Assessment and Evaluation.

• Manage the APS activities for sterile injectable vials, cartridges, pre fill syringes, and pens.

· Share knowledge and expertise with respect to start up and validation including utilities and equipment.

• Drive enhancement of sterile standards within the manufacturing environment.

Resolve complex problems by applying sound sterile operation principles, utilizing knowledge from FDA & European regulatory guideline, PDA and Annex 1 requirement.

• Investigate Deviations and conduct Root Cause Analysis.
• Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Support product preapproval inspection. The role has direct interaction with regulatory agencies during site inspections.
• Understand and implement manufacturing control strategy for various unit operation areas.
• Define enabling studies necessary for product submission and conduct those internally and externally with collaboration from different departments.

Basic Qualifications and Capabilities:

• Bachelor's degree in microbiology, engineering, or a related discipline.
• 8 years in a sterile cGMP production environment.
• Direct experience with APS including knowledge of the requirements of Annex 1 and PDA technical reports.
• Must have extensive hands-on experience in the development of aseptic programs including Clean Room Qualification, and Environmental Monitoring.
• Experience with biological production processes.
• Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.

Preferred Qualifications:

• A post graduate degree is preferred.
• Experience with cleaning validation strongly preferred.
• Direct interaction experience with regulatory agencies.

Shift: Day Shift. Monday through Friday.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk; sit; and reach with hands and arms. Furthermore, the employee must be capable of successfully passing aseptic gowning requirements, procedures, and certification. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.