EA2 - 2018
US ~ Boothwyn, PA
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.
PURPOSE OF JOB
The position may reside in any one of the functional areas
Support of validation activities.
Project Manage of engineering Tasks as assigned from the Garnet Valley Project (GVP).
Support the completion and maintenance of both equipment assessments, instrument assessments, and validation activities for New equipment for GVP
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- To support validation activities including, but not limited to, the following: review of validation protocols for equipment/systems; review/approval of OEM turnover packages; to complete drawing verifications; to generate/execute/witness commissioning documents (e.g. – FAT, SAT, etc.); to resolve discrepancies/deviations related to validation activities.
- Support the overseeing of the engineering documentation system which includes, but is not limited to, the following; ensuring that the maintenance documentation control program is proper maintained (e.g. – files are current with the required information; drawings required to be maintained in “As Built” status are properly updated; manuals are updated as needed); to ensure that electronic backups files are maintained in current status (e.g. – PLC code; HMI application files; computer software versions; VFD configurations, etc.).
- To support the completion and maintenance of both equipment impact and instrumentation assessments. This includes, but is not limited to, the following; collaborating with process owners and Quality Assurance to determine the classification of equipment/instruments; to generate assessment forms, as assigned; to revise assessments, as required.
- To support internal process improvement projects for Facilities Engineering. This includes, but is not limited to, the following: Generation of implementation plans; generation of SOPs; generation and analyzing of performance metrics to determine areas of improvement
ADDITIONAL POSITION REQUIREMENTS
- Is available for other duties, as required
- Is available for overtime , as needed
- Escorts and Supervises external contractors in association with assigned activities.
EDUCATION and/or EXPERIENCE:
- B.A. or other suitable degree relating to the position
- Desired: Bachelor of Science.
- Recent Graduate of a 4 year College degree
- Must be fluent in the English language, both written and verbally.
- Basic mathematics and geometry
- Must be able to utilize technical documentation (e.g. - manuals, specifications, drawings, etc.) to complete assigned maintenance activities.
- Must be able to assist in root cause analysis of instrumentation/equipment failures.
- 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).
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
- Required: Proficiency with Microsoft Office products including: Word, Excel, Power Point, and Outlook.
- Required: Ability to work independently as well as with others in a team environment.