US ~ Boothwyn, PA
Senior Validation Engineer
Our growing and successful business comprises of over 900 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, specialising 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.
Under minimal direction of the Director, the Senior Process Validation Engineer is responsible for owning the assigned Technology Transfer, Process Validation, Continuous Process Verification and Cleaning Validation of potential Products intended for Commercial manufacturing in a timely manner.
The core work of a Senior Process Validation Engineer will include process improvement and optimization, observation of batch executions, technical writing such as (but not limited to) protocols, reports, memorandum, SOPs, quality incidents and their investigations, APR, MBR, change controls and other regulatory documentation in a timely manner, and being the source of knowledge of the assigned Products as its Subject Matter Expert. The core competencies include the following:
- Small molecule process improvement, trouble shooting and optimization.
- Author and review of documents, verifying data, input of data, statistical analysis & interpretation, processing quality investigation close outs.
- Author batch records, ETPs and GMP protocols.
- Support Commercial manufacturing in trouble shooting and post launch. Provides commercial manufacturing with training material, issuance of batch records & associated documentation as needed.
- Attend project related meetings to provide Realtime updates.
- To comply & adhere to cGMP & GDP guidelines and regulations as required of this role.
- Responsible for ensuring compliance and follow procedures that govern the work performed in this role.
Main tasks and responsibilities will include:
- Understands formulation development. Capable of providing meaningful review of registration batch documents.
- Responsible for DOE studies to establish foundation for future CPV efforts.
- Understands SUPAC.
- Understands method development and impact of specifications to quality of product.
- 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/or clients, Commercial manufacturing management, and QA regarding the design and execution of pilot and commercial process parameters, master batch record writing, batch execution, and post batch evaluation and analysis.
- 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.
- 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.
- Communicates to management on all overview of assigned products.
- Hands on observation, keen technical eyes to details and generated observation notes during batch manufacture and trials.
- Prepare, approve & execute all necessary documentation, reports, protocols, batch records, etc. as required.
- Perform process improvement projects and troubleshoot production processes.
- Review SOPs and performance goals to ensure they reflect a commitment to quality and efficiency.
- NLT 95% compliance at a minimum in all training required to conduct the job.
- Perform other duties as assigned.
Additional tasks and responsibilities:
- Power point presentation skill
- Clear Communication skill (Verbal and written)
- Mentoring junior engineers and support staff as directed.
The job involves the following:
- Very high concentration of work at times and at regular intervals
- Strict and tight agreed upon deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Organizational skills
- Basic Computer skills
- Ability to take appropriate actions in cases of emergency, critical or hazardous situations.
- Ability to work with others in a team environment.
- Attention to detail
- Attend client meetings and generate orderly meeting timelines
- Bachelor's Degree in Pharmacy, Pharmaceutics, Chemical Engineering, Sciences or its equivalent
- Minimum 10 years of experience in a cGMP manufacturing environment encompassing the summary of job requirements.
- Must be experienced with scale-up and statistical process control; and process flow diagrams.
- Lean six sigma certification or excellent understanding of the lean process is a must.
- Exhibits excellent process development skills and is independent. Must be capable of training and mentoring junior staff.
- Manages projects to deliver results on time and on budget.
- Proficient in Process Safety concepts and methodology.
- Focused on Meeting Customer Needs.
- High degree of professionalism, ethics and integrity.
- Incumbent must be accountable for own actions and complies with the governing laws and company policies.
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.