Job Description

The Quality Engineer II – Combination Products will join the Civica, Inc. (“Civica”) Quality organization at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.   

Responsibilities of the position include working across functions to provide hands-on Quality oversight and Quality Engineering input to develop maintain drug delivery device/ combination products for small and large molecules.

Responsibilities of the position include supporting quality management systems and oversight to ensure the product process validation, equipment qualification, and Quality Risk Management meet cGMP and Civica compliance requirements leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.   

The position is an onsite role at Civica Petersburg, Virginia facility.

Essential Duties and Responsibilities:

• Working across functions, to ensure and provide Quality oversight of the establishment and maintenance of Civica’s quality systems related to pre-filled injectable syringe and pen combination products. 

·      Work with cross functional teams to provide Quality oversight for validation and qualification activities and ensure work for developed drug delivery device/ combination products for small and large molecules is performed in a compliant and controlled manner. 

• Support evaluation and validation of packaging solutions.
• Partner with the medical device development team to ensure all elements of the design history file are executed and maintained.
• Ensure Product Development and Design Transfer Plans are in accordance with CFR 820 quality system regulations and ISO 13845 medical device standards.
• Support process development and technology transfer of combination products.
• Provide quality support for all operational compliance aspects of sterile fill finish manufacturing of combination products including but not limited to batch record review and batch release. 
• Ensure Standard Operating Procedures, and training is in place to maintain compliance with cGMP.    
• Maintain current knowledge of local and international combination product and medical device regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), complaints and management notification.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.

·      Support product process transfers, including validation, from and/or to other manufacturing sites. 

·      Support activities related to combination product(s) introduction to the site. 

·      Generation, review and/or approval of policies, procedures, reports, and other records.  

• Participate in Quality Risk Management and analysis. 
• Participate and support other commissioning, qualification, and validation activities as needed.

·      Support product process transfers, including validation, from and/or to other manufacturing sites. 

·      Support activities related to product introduction to the site. 

·      Provide quality review and support for laboratory method validation/verification and laboratory information management system (LIMS). 

·      Provide support to equipment, facilities and utilities qualification as needed. 

·      Work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions. 

·      Travel (up to 5%) may be required. 

Basic Qualifications and Capabilities:

·      Bachelor’s degree in a scientific discipline with 6+ year’s Quality/cGMP experience in the pharmaceutical industry.   

·      CFR Part 4 Regulation of Combination Products compliance expertise (i.e., pre-filled injectable pens)

·      CFR 820 quality system regulations and ISO 13845 medical device standards expertise.

·      Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required. 

·      Experience in sterile injectable manufacturing and packaging operations is required.

·      Experience in Quality Risk Management and Analysis for Combination Products.

·      Regulatory Inspection Knowledge and understanding for Combination Products experience

·      Participation and leading activities to support regulatory agency inspections required. 

·      Project management, organization, and execution skills are required. 

·      Excellent interpersonal and written communication skills and experience using various software/electronic applications required.

·      Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.

·      Ability to work autonomously and within established guidelines, procedures, and practices.

·      Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.

·      Experience in process, technical transfer and validation of combination products. 

·      Ability to apply technical expertise to solve problems and issues. 

·      Continuously striving for opportunities to learn, build skills, and share knowledge with others. 

Preferred Qualifications:

Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices.

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. 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.