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9 Month CONTRACT role with strong potential to extend for the right candidate. Seeking a strong CLEANING VALIDATION specialist. Start ASAP with possibility to extend after December 2024. Pay range 55-70.

Lenox Executive Search is seeking an experienced Cleaning Validation Specialist to fill a 9 month extendable contractual role with a global pharmaceutical company in .Swiftwater, PA. Must have 2 total years of CLEANING VALIDATION experience working in a biologic, vaccine or pharma industry

REQUIREMENTS for the 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 develop cleaning cycle and lead the investigation or trouble shooting.
o Ability to review and analyze data.

• Cleaning Validation experience

o Acceptance criteria determination
o Sampling plans and sample size determination
o Rinse and Swab sampling experience
o Bracketing and worse case rating
o QC testing requirements
o 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: $55.00 - $70.00 per hour

Expected hours: No less than 40 per week

Benefits:

• Flexible schedule
• Health insurance
• Paid time off

Payment frequency:

• Paid biweekly

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Pharma industry Cleaning Validation: 2 years (Required)
• authoring, reviewing, executing validation document: 2 years (Required)
• GMP root cause analysis: 2 years (Required)

Ability to Commute:

• Swiftwater, PA 18370 (Required)

Ability to Relocate:

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

Work Location: Hybrid remote in Swiftwater, PA 18370