Cleaning Validation Specialist

• Experience in Cleaning Validation in the biologics or vaccine industry to include the following:
• o Experience in
• authoring, reviewing, executing and approving validation documents.
• o Interface with Quality organization and the ability to defend rationale in validation documents.o Ability to d
• evelop cleaning cycle

and lead the investigation or trouble shooting.o Ability to review and analyze data.

• Cleaning Validation experience

o Acceptance criteria determinationo Sampling plans and sample size determinationo Rinse and Swab sampling experienceo Bracketing and worse case ratingo QC testing requirementso Dirty hold times and clean hold times

• EXCELLENT communication skills
• Ability to manage, execute and troubleshoot on their own
• Strong Microsoft Suite skills (Word, Excel, Project, Outlook)
• BS/MS degree
• 2+ total years of experience working in a biologic, vaccine or pharma industry
• Experience writing and revising documents (e.g. testing methods, protocols, reports)
• Experience performing testing in a GMP setting
• Proficiency in utilizing documentation system to author protocols and reports
• Experience participating in teams and collaborative work environments.
• Team environment a must
• E Doc/GEODE+ experience with a working knowledge of templates, workflows and approval process
• Strong root cause analysis with cGMP experience.
• Mainly M-F with some flexibility in working hours. Will work some form of 8 hours within 7am and 5pm. Manager flexible. Must be open to very occasional weekend work or overtime if needed. May also need to switch a shift from morning to afternoon on occasion.
• Start ASAP with possibility to extend after December 2024.
• Mostly hybrid - will usually be 4 days onsite and one remote but manager prefers flexibility just in case they are needed onsite the extra day.

Job Type: Contract

Pay: Up to $55.00 per hour

Schedule:

• 8 hour shift
• Day shift

People with a criminal record are encouraged to apply

Experience:

• Cleaning Validation: 4 years (Required)
• biologics or vaccine industry: 5 years (Required)
• GMP: 4 years (Required)
• CGMP: 1 year (Required)
• Root cause analysis: 4 years (Required)
• Medical documentation: 4 years (Required)

License/Certification:

• Driver's License (Preferred)

Ability to Commute:

• Swiftwater, PA 18370 (Preferred)

Ability to Relocate:

• Swiftwater, PA 18370: Relocate before starting work (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: In person