PVE - 2019
US ~ Boothwyn, PA
Process Validation Engineer
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
The Process Validation Engineer is responsible for ensuring the successful technology transfer, process validation and continuous process verification efforts of commercial solid dosage drug product. The position requires an in-depth understanding of QbD, DOE, CPP, CQA, process validation, cleaning validation and product robustness related activities. It is preferred to have hands on experience with manufacturing equipment, processes and utilities. The validation Engineer is required to write technical documents, execute and review complex protocols and coordinate validation activities in coordinated efforts with other departments.
Other tasks and responsibilities will include:
- Write, execute, and review validation protocols and reports.
- Responsible for designing, conducting and coordinating scientific studies for physical/chemical characterization and process development.
- Perform scale up development and optimization of manufacturing process based on regulatory guidelines related to pharmaceutical development (such as ICH Q8, Q9 & Q10).
- Collaborate with formulators and technicians regarding the design and execution of pilot and commercial process parameters, creation of formulation spread sheets, master batch record writing, batch execution, and post batch evaluation and analysis.
- Compare results against acceptance criteria and bring exceptions and deviations to management’s attention.
- Executes experiments at lab scale and commercial scale to implement the use of quality by design (QbD) principles and design of experiments (DOE) to develop robust process parameters. Design the experiments using statistical software is a plus.
- Evaluate retrospective quality by design (QbD) assessments of currently marketed products to improve quality, efficiency and mitigate potential cGMP and quality risk.
- Review batch records, incident investigation reports, change controls, market complains, annual product review, product development protocols and reports, drug master files, validation documents, equipment qualification reports, stability data, raw material data trend, CAPAs, in process and finished product analytical data for understanding the process knowledge and identify the risks to the quality of the product.
- Work with Quality Assurance to ensure protocols and reports get approved.
- Coordinate validation activities with other departments.
- Administer Quotients site Change Control procedures.
- Monitor and direct the daily validation activities including the manufacturing personnel’s performance and training.
- Oversee other tasks and responsibilities as assigned.
- Handle multiple projects and work independently.
- Have the ability to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
- Adheres to all safety procedures and hazard communication.
- Ability to work over-time may be required to meet production schedules.
- B.A. or B.S. in Pharmacy, Chemical Engineering, or related science
- 2-5 years of experience in Tech transfer and Commercial Validation Process, Solid Dosage Manufacturing, Quality or an equivalent combination of education and experience.
- Knowledge of the regulatory and cGMP regulations for pharmaceutical manufacturing operations, and validation procedures and practices.
- Excellent organizational and time management skills.
- Excellent verbal and written communication, interpersonal and communication skills.
- Ability to communicate knowledge to peers and colleagues from other departments requiring a thorough understanding of processes, equipment and facilities.
- MS Word, Excel and Projects experience.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.