90% of the work will be revalidation of equipment, cleaning, and monitoring of equipment for the aseptic process.
Revalidations include depyrogenation tunnels for fillers, vial and cartridge washers, autoclaves, component prep equipment sterilizers, CIP skids, SIP skids, and vessels.
All revalidations are performed on a yearly basis and are already scheduled for the bulk of the year.
The role involves learning the process, performing revalidations and cleaning monitoring activities, compiling data, and writing reports to be submitted to regulatory agencies and archived in-house.
Experience with Elab is a bonus; experience with K validators is also relevant.
Comfortable with data analysis and report writing.
10% of the role involves working with other projects in resource groups.
Flexibility to work outside of normal hours is needed, with comp time offered for weekend work.
Looking for someone who is willing to learn and flexible.
The team culture requires openness to working with different groups across the aseptic production area, including shift teams, maintenance technicians, and equipment engineers.
Candidates with lab technician experience, performing aseptic sterilization and working on equipment in a laboratory setting, would be considered.
Basic grasp of validation principles and equipment is important.
Candidates with strong quality control backgrounds and hands-on pharma experience with a solid understanding of validation principles would be considered.
Education / Experience:
Bachelor's degree is required for the role.
Experience in cleaning and monitoring can be a match even without specific validation experience.
Top 3 Technical Skills:
Equipment revalidation: Experience with depyrogenation tunnels, autoclaves, washers, and sterilization equipment is essential for performing revalidation tasks.
Data analysis: The role requires analyzing collected data from revalidation and cleaning processes to ensure compliance and identify potential issues.
Report writing: Proficiency in writing clear and concise reports to document validation activities and findings for regulatory submission and internal archiving.
Soft Skills:
Due to the 24/7 nature of the operations, the candidate must be adaptable and willing to work outside standard hours, including weekends, as needed to meet project demands.
The Validation Area Specialist will collaborate with various teams, including shift teams, engineers, and maintenance, so the candidate should be a team player and have great interpersonal skills.
HM is open to candidates with limited experience, emphasizing the importance of a proactive and eager approach to learning the company's processes and systems.
Pay Transparency: The typical base pay for this role across the U.S. is: $25.00 - $25.63/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
How strong is your resume?
Upload your resume and get feedback from our expert to help land this job
How strong is your resume?
Upload your resume and get feedback from our expert to help land this job