Job Profile: GxP Lab Computing Engineer
Company Name: TEKsystems
- TEKsystems
- Waltham, MA, United States
- via TEKsystems Careers
- 11 hours ago
- $40–$50 an hour
- Full–time
Qualifications
- 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
- 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
- Robotic Systems Integration & Qualification
- 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
- 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 of TEKsystems
- 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)
Responsibilities
- 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
- Knowledge of laboratory safety practices as defined by the company and/or customer’s site safety code
- As a Lab Computing Analyst, beneficiary would perform following key responsibilities:
- Requirements Management and onsite Validation/Compliance support
- Onsite Lab IT Support
- 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
- 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
- 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
- Clinical study planning & Data management
- Lab Workflows
- Chemical & Biologics material Management
- Operations KPI and Metrics tracking
Job description for TEKsystems
Description:
In addition to analytical and technical laboratory services, the Lab Computing Engineer offers consultancy and multivendor instrumentation, information technology, and, when necessary, in-lab validation and compliance services. The person will offer the consulting abilities needed to assess the gaps in the needs of the client and suggest solutions for the ideal condition. He or she will collaborate with the internal support staff and business users and customer managers.
Necessary Competencies:
Outstanding interpersonal skills combined with the capacity to hear and understand client requests
Capacity to troubleshoot complicated technological and instrument problems
strong communication abilities both in writing and speaking
the capacity to recognize, monitor, and finish work for several projects
understanding of laboratory safety procedures as outlined in the site safety code of the customer or the company
Accountabilities:
As a Lab Computing Analyst, the recipient would carry out the following primary duties:
Management of requirements and on-site assistance for compliance and validation
IT Guidance
Client Relations
On-site IT Support for Labs
Management of Requirements
Recognize the issues and/or problem statement
Define the parameters.
Compile the necessary information.
Help with IOPQ (Validation/Compliance) tasks as needed.
Examine the needs and business procedures as they stand right now.
aid in creating ideas for enhancing the process
IT Guidance
Examine areas that could want improvement based on industry best practices.
Analyze market trends to pinpoint areas that could use improvement.
Assess vendor offerings and arrange prototype demonstrations as Proofs of Concept.
Suggest process enhancements that align with business requirements.
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 are collaborators in change. We assist clients in bringing concepts and solutions to life so they can seize fresh opportunities. With 80,000 employees, we serve over 6,000 clients in North America, Europe, and Asia, including 80% of the Fortune 500. Leading the way in talent services, full-stack technology services, and practical application, we collaborate with forward-thinking executives to effect change. That is the actual partnership’s power. One firm in the Allegis Group is TEKsystems.
Being an equal opportunity employer, the company will evaluate all applications without discrimination based on any protected trait (genetically or otherwise) or based on race, sex, age, color, religion, national origin, veteran status, handicap, sexual orientation, gender identity, or age.
