| Employer: | UtahTechnologyJobs.com |
| Job Location: |
Salt Lake City - Salt Lake County |
| Employment Type: | Full Time |
| Salary Range: | $70k negotiable DOE |
Description: |
Parallel HR Solutions is searching for an experienced Software/Systems Validation Specialist & Project Manager for our client, a cutting edge pharmaceutical and microbiology testing laboratory.
The Software/Systems Validation Specialist & Project Manager will help our client in their development of new software and systems to advance their laboratory testing. We are looking for candidates with specific FDA validation experience, specifically with laboratory software and systems. Viable candidates will also have experience working with scientific staff and software development staff members alike—recording and translating needs to workable projects, and managing the entire process.
The Software/Systems Validation Specialist & Project Manager will work with two departments: Quality Assurance and IT. The Software/Systems Validation Specialist & Project Manager will have the following primary functions: lead projects from inception to completion; develop requirements and specifications for lab software; and lead and manage teams of experienced professionals with diverse skills—from laboratory scientific staff, Software Development and IT, to senior and executive management.
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Duties: |
The Software/Systems Validation Specialist & Project Manager will
1. Document requirements and format into established templates.
2. Translate requirements into technical specifications.
3. Facilitate meetings, take copious notes, translate, etc.
4. Place project requirements into established/required format and describe how the system can be tested against.
5. Create and complete checklist of project items, in the end validating that the system works as designed.
6. Work in tandem with a developer and write technical specifications.
7. Work with teams of professionals in developing validation protocols
8. Complete Validation reports.
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Qualifications: |
• Bachelor’s degree with a minimum 2+ years of relevant experience or equivalent
• Strong Project Management experience
• Quality Assurance experience, specifically in validating software and IT systems to meet FDA regulations
• Ability to apply statistical analysis to equipment / system data output is required
• Prior experience in a Microbiology environment is preferred. Working knowledge of current Good Manufacturing Practices (cGMP) and familiarity with the Code of Federal Regulations (CFR).
• Capable of moderately complex troubleshooting
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Strong problem solving, time management and organizational skills.
• Demonstrated ability to multitask and consistently meet deadlines
• Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
• Excellent written and verbal communication skills. Ability to communicate effectively with others and to train others
• Demonstrated initiative through past experience
• Ability to work effectively both independently and as a member of a team
• Ability to lift up to 30 pounds using proper lifting technique
• Knowledge of instrumentation, processes and facilities equipment a PLUS, but not required.
Work Schedule: M-F 8/9:00AM – 5/6:00PM with some flexibility
Next Steps
Submit your resume and cover letter to Parallel HR Solutions and include the following information:
1. Specific type and amount of experience
2. Availability
3. Compensation expectations and current salary
4. Your authorization for Parallel HR Solutions to represent you for this specific position
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