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Full-time hourly position - competitive salaries, career advancement opportunities, a bonus plan, excellent benefits package including a matching 401K, health, dental, vision and tuition reimbursement.
Full-time and hourly positions - competitive salaries, career advancement opportunities, a bonus plan, excellent benefits package including a matching 401K, health, dental, vision and tuition reimbursement.
Job Summary:
Responsibilities for this position involve validation equipment operation, protocol development, protocol execution and associated activities.This position will support a wide range of validation activities, including laboratory and manufacturing equipment of all types, laboratory and manufacturing technical support services, facilities/utilities, computerized systems and data integrity assessment/remediation.
This full-time position works with supervision to gain experience with more experienced staff.
This position is for day shift but may require some occasional off shift overnight and/or weekend coverage to accommodate schedules and/or project timelines.
Essential Duties and Responsibilities:
- Directly support validation projects at external client sites
- Operate validation test equipment: process meter, data logging systems
- Independently develop and execute validation protocols and procedures
- Perform CSV (computer software validation) and data integrity assessment/remediation
- Support deviation resolution and troubleshooting strategies with client
- Provide technical support to laboratory and/or manufacturing areas
- Support positive client interaction and communication
- All other duties as assigned
Education, Experience and Qualifications:
- BA/BS in technical or science field of study. Candidates with an HSD/GED, technical training, or an Associate’s degree combined with mechanical aptitude or relevant industry experience
- Strong working knowledge of IT concepts, strategies, and methodologies
- Proficient with Microsoft Office (Word Excel, Powerpoint)
- Strong written and verbal communication skills
- Strong mechanical skills
- Strong reporting, organizational and interpersonal skills
- Ability to multitask and to perform tasks with high quality and accuracy
- Validation experience or experience working in a GMP regulated environment is a plus, including working knowledge of ISO 9001, ISO 17025, GMP, GLP, GAMP 5 and 21 CFR Part 11
Additional Information:
- Drug testing
- Inoculations specific to customer sites
- Travel required
- Valid driver’s license