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GxP Lab Computing Engineer
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Description:
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.
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
Additional Skills & Qualifications:
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
Optional requirement: 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
Benefits:
About TEKsystems:
We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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.
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
Additional Skills & Qualifications:
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
Optional requirement: 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
Benefits:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
About TEKsystems:
We're partners in transformation. We help clients activate ideas and solutions to take advantage of a new world of opportunity. We are a team of 80,000 strong, working with over 6,000 clients, including 80% of the Fortune 500, across North America, Europe and Asia. As an industry leader in Full-Stack Technology Services, Talent Services, and real-world application, we work with progressive leaders to drive change. That's the power of true partnership. TEKsystems is an Allegis Group company.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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