Responsibilities:
- 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
Additional Responsibilities:
- Audit response
- Validation
- Lab Administration
- PER requests
- Investigations
- Data backup configuration
- Software: training and advanced end user
- Data integrity assessments
- Training
- Repair systems
- Technical SME
- SOP Authoring
- Implement continuous improvement
- Write change control requests and test plans
- Professionalism, excellent listening skills, superior analytical skills, great verbal and written communication skills
- Ability to manage one's time with minimal supervision to achieve objectives
Basic Qualifications:
Associate degree in Computer Science or Life Science AND 2+ years of relevant technical experience including (but not limited to); Windows technologies, manufacturing systems, networking, technical writing
Prior 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/manufacturing instrumentation/equipment is a benefit
- Experience with file systems, software configurations, security, audit trails and tracing data flows within programs.
- Experience with manufacturing environments and/or working in and with GMP regulated environments and systems
Other Requirements:
- 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 •
Last updated on Nov 27, 2023