Validation & Compliance Specialist
Albany, New York | Rensselaer, New York
Responsibilities
Location Albany, New YorkUS Job ID JR-032679Job Description Summary
- 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.
- Has knowledge/education in GxP or similar type organization and Information technology disciplines within regulated industries.
Job Description
- Worked in a GMP manufacturing environment
- Is familiar with and may have worked on, manufacturing automation systems
- Experience with IT systems management and associated processes
- Has provided support for manufacturing and/or IT systems
- Undergraduate degree, though extensive experience may substitute
- Writing skills are very important as they will be documenting complex aspects of the system
- Experience with file systems, software configurations, security, audit trails and tracing data flows within programs.
Responsibilities:
- Including but not limited to the following.
- 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
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
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
