Responsibilities

Responsibilities:

• Performs the calibration and validation of test and data analysis equipment and systems used for clinical research, trials and product testing.
• Assists in equipment selection, specification and negotiation of competitive pricing.
• Maintains all documentation pertaining to qualification and validation. May develop procedures and/or protocols.
• Also serves as information resource for validation technicians, contractors and vendors.
• Translate technical information and requirements into qualification/validation test design documents
• Sets work expectations with customers and delivers against them.  Familiar with software deployment and development life cycles.  Possess excellent customer consulting, written and communication skills.

• Learn and understand the system processes and procedures of the Customer’s Stand Alone or Enterprise Computerized system
• Document system and use processes and procedures for Customer review and approval
• Provisioning users on systems undergoing validation and document steps
• Track down root cause of errors during qualification and testing of systems undergoing validation activities and document solutions.
• Assist with system configuration and changes as directed by Client Lead and document results/procedure to configure
• Perform and assist with planning and support activities associated with bringing new computerized systems on-board throughout the year and document configuration details
• Use BMRAM and DocCompliance for change control and project management as directed by Client Lead
• Generate validation documentation for use

Basic Qualifications:

• Associate degree in Computer Science or Life Science
• 2+ years of relevant technical experience including (but not limited to); Windows technologies, manufacturing systems, networking, technical writing
• Has knowledge/education in GxP or similar type organization and Information technology disciplines within regulated industries.

Preferred Qualifications:

• Bachelor's degree in Computer Science or Life Science
• Experience with Technical Writing – Preferably Standard Operating Procedures or Technical Evaluation documents.
• Experience with scientific/manufacturinginstrumentation/equipment is a benefit
• Experience with manufacturing environments and/or working in and with GMP regulated environments and systems

Physical Demands:

• Must be able to remains in a stationary position more than 25% of the time
• The person in this position needs to occasionally move inside and outside labs
• Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function. 
• Regularly move or lift up to 25 pounds and occasionally move or lift up to 100 pounds  
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range (within a few feet of the instrument), distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position. 
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer

The annual compensation range for this full-time position is $73320.00 to $109720.. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.