Instrumentation and Controls Specialist
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 help biotech and pharma customers 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.
- Front-end Administrator for the GxP Building Automation System/Monitoring System.
- Provide support for maintenance and process instrumentation activities.
- Execution of assigned maintenance activities, which will include various functions within a Computerized Maintenance Management System.
- Support the design, specification, and installation of new/renovated process equipment and facilities modifications.
- To comply & adhere to Good Manufacturing Practice (GMP) standards.
Main tasks and responsibilities will include:
- To complete process instrument audits for generation of Equipment/Instrument Impact Assessments. Audits include proper identification of instrumentation loop components and compiling critical documentation pertaining to each component (e.g. – manuals, specifications, configuration/setup sheets, etc.).
- GxP Administrator of the Building Automation System.
- Support HVAC and Utility Systems corrective maintenance.
- Install/troubleshoot/repair equipment/instruments/components related to controls.
- Evaluates, prepares, and executes quality events documentation such as change controls, deviations, and corrective/preventive actions.
- To provide support and recommend continuous improvement initiatives utilizing lean manufacturing tools and/or other techniques.
- Performs other related duties as required and assigned.
- Prepares technical reports with recommendations for solutions to technical problems.
- Reads, writes and follows Standard Operating Procedures (SOP’s).
- Writes IQ/OQ/PQ’s, Out-Of-Tolerances (OOT’s) and Deviations related to calibrations.
- Ensures timely completion and compliance with cGMP and all other relevant company training requirement.
- Supervises external contractors in association with assigned maintenance activities.
- Manages, maintains, and redlines drawings and documentation related to BAS systems.
- Manage lifecycle of software/hardware/firmware for qualified systems and equipment to maintain current versions and avoid obsolescence.
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, as needed
- Needing to respond to client demands
- Frequently required to stand, sit, or walk
- Occasionally required to climb, balance, bend, stoop, kneel or crawl
- Continually required to talk or listen
- 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 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 meet OSHA requirements to wear respiratory personal protective equipment (PPE).
- Required: Bachelor of Science or specialty degree/certification from a vocational institution. Degrees related to information systems/technology is preferred.
- Required: Working knowledge of; low/line voltage controls, PLCs, P&ID/wiring diagrams/schematics, VFDs, pneumatic controls, transmitters, loops, safety interlocks, etc.
- Desired: 1-3 years of experience of HVAC controls.
- Desired: 1-3 years of working with a Supervisory Building Automation/Monitoring System.
- Desired: Minimum of (5) years of working in a FDA regulated GxP environment, an ISO 9002 environment, or other regulated environment with a defined quality system (e.g. – nuclear).
- Desired: 1-3 years performing process instrumentation calibration.
- Desired: 1-3 years of direct usage of a CMMS.
- Desired: 1-3 years of supporting or executing Validation (IQ/OQ/PQ) activities.
- Desired: 1-3 years administrating GxP equipment monitoring systems (e.g. RMS, Rees)
- Must be fluent in the English language, both written and verbally.
- Must be able to assist in root cause analysis of instrumentation/equipment failures.
- Required: Proficiency with Microsoft Office products including: Word, Excel, and Outlook.
- Required: Ability to work independently as well as with others in a team environment.
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.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at email@example.com.