Senior Process Engineer
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica’s mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country’s most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.
With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023.
In this role, you will supervise the development and validation of manufacturing processes for pharmaceutical products. Additionally, you will review and approve protocols, master batch records, product impact assessments, sampling plans, technical reports, and provide technical assessments, rationales and approval for engineering and process changes and documentation pertaining to process development, qualification, and validation to meet regulatory requirements.
Essential Duties and Responsibilities
- Build quality into products and processes using Quality by Design (QbD) and Design Control for drug/device combination products
- Participate in the development of Quality Target Product Profiles (QTPPs)
- Review development protocols and design of experiments to identify critical quality attributes, critical material attributes, and critical process parameters
- Review validation project plans and process validation documentation
- Write and review CMC sections for ANDA filings
- Establish risk analysis processes to improve quality
- Resolve complex problems by applying sound engineering principles, utilizing experimental, and analytical methods to a range of technical product development challenges over a range of products from simple sterile injectable vial products to more complex pre-filled syringe combination products and oral solid dosage forms
- Support investigations and atypical events, as well as resulting corrective or preventive action implementation
- Root cause analysis facilitation/participation
- Support and supervise the work of contract development and manufacturing organizations, from contract development to technology transfer and process validation
- B.S. Degree in Engineering or related field
- Possess 7-12 years of experience in the Pharmaceutical field
- Knowledge of a wide range of pharmaceutical products and processes is preferred, especially parenteral products
- Knowledge of pharmaceutical process validation
- Knowledge of the product development process for ANDAs
- Willingness to travel up to 20% of time (preferred)
- Demonstrated ability to effectively communicate and negotiate a diversity of issues
- Key to this position is the demonstrated ability to provide technical leadership and teamwork in a cGMP environment across functional and organizational boundaries
- Ability to effectively collaborate with others to achieve team goals and expectations.
- Effective time management and prioritization skills.
- Outstanding organization skills and attention to detail.
- Self-starter, mature, independent, and dependable.
- Ability to work in a fast-paced environment under pressure, able to multi-task and obtain results.
- Ability to maintain high degree of confidentiality and use of appropriate discretion and independent judgment.
- Completes documents clearly and accurately. Writes clear and accurate technical documents.
- Excellent communication skills are a must
- Ability to assess and develop timely, effective solutions for products and processes is key