GxP Lab Computing Engineer
Location: Cambridge, MA (Onsite)
Duration: 12 month
MOI: Virtual
***Looking for candidates with “EMPOWER” experience
The Lab Computing Engineer provides both consulting, analytical and technical laboratory services, including multivendor instrument, information technology as well as in-lab validation/compliance services when applicable. The individual will provide the consulting skills required to analyze customer needs and gaps to propose solutions for the desired state. He or she will work with business users and managers of customers in conjunction with the internal support team.
Requirements
Required Skills:
Excellent customer service skills complemented by an ability to listen to and interpret client requests
Ability to troubleshoot complex instrument and technology issues
Strong oral and written communication skills
Ability to identify, track and complete tasks for multiple projects
Knowledge of laboratory safety practices as defined by the company and/or customer’s site safety code
Responsibilities:
As a Lab Computing Analyst, beneficiary would perform following key responsibilities:
Requirements Management and onsite Validation/Compliance support
IT Consulting
Customer Liaison
Onsite Lab IT Support
Requirements Management
Understand problem statement/challenges
Define scope
Gather requirements.
Assist with Validation/Compliance activities (IOPQ) as required.
Analyze current state business processes and requirements.
Assist in building plans for process improvement
IT Consulting
Analyze gaps/opportunities for improvement based on industry Best Practice
Evaluate Industry trends to identify areas for optimization
Evaluate vendor solutions and facilitate demos of prototypes as Proofs of Concept
Recommend process improvements that fit business needs
Customer Liaison:
Meeting with internal/external service groups/leads
Liaise between System/Lab owners and third parties to coordinate best times for services
Provide weekly planning schedules for review at status meeting with customer leads
Monthly Operational review meetings/ Quarterly metrics reporting with department heads
On Site Lab IT Support:
Perform break/fix support for all Instrument connected systems
Implement Windows based security policies as required
Ensure adherence to client’s corporate policies through periodic reporting & compliance programs
Acts as the technical support contact for field service engineers and external vendors
Provide technical subject matter expertise for new system validation and change management
Create and maintain a physical inventory of lab equipment, PC’s, software, and any other information pertinent to the environment if applicable
Perform system preventative maintenances based on client’s schedule, if applicable
Requirements
- Bachelor’s/Master’s degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical
- At least 5 years of directly relevant experience, including:
- At least 3 years in software development and testing.
- At least 2 years of experience in business requirement analysis and gathering.
- Demonstrated domain area knowledge.
- Candidate must possess excellent analytical and interpersonal skills along with a proven track record in system design, implementation, have demonstrated ability to guide the activities of colleagues, and have demonstrated ability to gain client’s confidence and trust.
- Candidate must demonstrate in-depth understanding in one or more of the following areas of Bio/Pharma industry:
- Drug Discovery & Development Processes
- Clinical study planning & Data management
- Lab Workflows
- Chemical & Biologics material Management
- Sample Management
- Robotic Systems Integration & Qualification
- Operations KPI and Metrics tracking
- Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820
Technical Skills:
Operating System familiarity with at least 1 of the following: Unix, Windows, MVS
Software Methodology familiarity with: Object Oriented Programming, Structured Programming
Software Development Process familiarity with: Waterfall, Agile
Change Control Management and Risk Management
Office Tools proficiency required in : MS Word, Excel, PowerPoint
Office productivity tool proficiency in at least 1 of the following: Visio, MS Project, SharePoint.
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