Senior Validation Engineer
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- Provide senior level engineering support for maintenance and validation activities
- Execute validation procedures and develop protocols for new and existing equipment
- Maintain engineering and validation records in both hard copy and electronic form
- Support and maintain equipment impact, instrument, and re-validation assessments
- Manage the design, specification, and installation of new/renovated process equipment and facilities modifications
- Lead, mentor, and coach junior level validation engineers
- Comply & adhere to Good Manufacturing Practice (GMP) standards
Main tasks and responsibilities will include:
- Manages the scope, deliverables, schedule, budget and quality of maintenance/engineering projects related to cGMP process equipment, utilities, controls and physical building. This may include generation/review of design documentation, participation in both factory and site acceptance testing, participation in equipment installation and facility construction activities.
- Responsible for the identification and mitigation of risks to ensure business continuity and protect the company from loss.
- Responsible for preparation and presentation of project status reports.
- Recommends and manages implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
- Evaluates, approves, prepares, and executes change control documentation, including like for-like component assessments.
- To provide support and recommend continuous improvement initiatives utilizing lean manufacturing tools and/or other techniques.
- Supports, leads and coaches junior validation team members
- Maintains compliance with applicable local, state, and federal regulations.
- Performs other related duties as required and assigned.
- Frequently required to stand
- Frequently required to walk
- Frequently required to sit
- Frequently required to utilize hand and finger dexterity
- Occasionally required to climb, balance, bend, stoop, kneel or crawl
- Continually required to talk or hear
- Continually required to smell
- Occasionally exposed to wet and/or humid conditions (non-weather)
- Frequently work near moving mechanical parts
The job may involve the following:
- Very high concentration of work
- Strict and tight 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
- BS Degree in Engineering and five (5) years Validation experience in a cGMP/cGLP regulated environment; or equivalent combination of experience, education and training.
- Bachelor of Science or specialty degree/certification from a vocational institution. Degrees related to information systems/technology is preferred.
- Minimum of one (1) year of working with CAD, or other graphical software packages. Alternately, formal training on CAD, or other graphical software package.
- Minimum of five (5) years of working in an FDA regulated GxP environment, an ISO 9002 environment, or other regulated environment with a defined quality system (e.g. - nuclear).
- Fluent in communications (verbal/written) in English
- Ability to work with mathematical typical concepts and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
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.