EA - 2019
US ~ Boothwyn, PA
US ~ Garnet Valley, PA
Our growing and successful business comprises of over 800 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.
- Provide engineering support for maintenance and validation activities.
- To maintain engineering documentation.
- Support the completion and maintenance of both equipment impact and instrument assessments.
- Manage the design, specification, and installation of new/renovated process equipment and facilities modifications.
Other 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.
- Maintains compliance with applicable local, state, and federal regulations.
- Performs other related duties as required and assigned.
- Required: Bachelor of Science or specialty degree/certification from a vocational institution. Degrees related to information systems/technology is preferred.
- Desired: Minimum of one (1) year of working with CAD, or other graphical software packages. Alternately, formal training on CAD, or other graphical software package.
- Desired: Minimum of one (1) year of working in a 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.
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Other Skills, Abilities, or Qualifications
- Desired: Proficiency with Microsoft Office products including: Project, Word, Excel, and Outlook.
- Desired: Ability to complete basic 2D CAD operations (AutoCAD or similar)
- Required: Ability to work independently as well as with others in a team environment.
- 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
- Occasionally work in high, precarious places
- Occasionally work around fumes, airborne particles, or toxic chemicals
- Occasionally exposed to outside weather conditions
- Occasionally exposed to extreme heat or cold (non-weather)
- The employee must occasionally lift and/or move up to 40 pounds
- Specific vision abilities required by this job include: Close vision; Distance vision; Color vision; Peripheral vision; Depth perception and ability to adjust focus.
- Must be able to met OSHA requirements to wear respiratory personal protective equipment (PPE).
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.