Seeking a strong CLEANING VALIDATION specialist with PRODUCTION MANUFACTURING experience for my Pharma client in Swiftwater, PA. Lab experience is not a good fit for this role. Start ASAP. Pay rate starting at $65/hour with flexibility for a strong candidate.

Highly motivated hiring manager who is interviewing quickly. This manager gives a VERY IN DEPTH AND TECHNICAL INTERVIEW and he quickly can discern if a candidate does not have the experience listed on their resume.

RESPONSIBIILTIES of the Manufacturing Production 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 timesREQUIREMENTS for the Manufacturing Production Cleaning Validation Specialist:

• 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.
• EXCELLENT communication skills
• Ability to manage, execute and troubleshoot on their own
• Strong Microsoft Suite skills (Word, Excel, Project, Outlook)
• 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.

Job Type: Contract

Pay: From $65.00 per hour

Expected hours: No less than 40 per week

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Pharma Manufacturing Production Cleaning Validation: 2 years (Required)
• CIP: 2 years (Required)
• COP washer: 1 year (Required)

Ability to Commute:

• Swiftwater, PA 18370 (Required)

Ability to Relocate:

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

Work Location: In person