GxP Lab Computing Engineer - TEKsystems

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:

• 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.