Cleaning Validation Specialist
2 weeks ago
Pay Rate: $70.00 to $75.00 per Hourly
Location: Swiftwater, PA (Hybrid)
Job Description:
Hybrid will usually be 4 days onsite and one remote but manager prefers flexibility
Manager is looking for stronger CLEANING Validation experience, not Computer Validation.
Description:
- THIS IS A CLEANING VALIDATION POSITION.
Duties
Experience in cleaning validation in the biologics or vaccine industry to include the following:
- Experience in authoring, reviewing, executing and approving validation documents.
- Interface with Quality organization and the ability to defend rationale in validation documents.
- Ability to develop cleaning cycle and lead the investigation or trouble shooting.
- Ability to review and analyze data.
- Cleaning Validation experience
- Acceptance criteria determination
- Sampling plans and sample size determination
- Rinse and Swab sampling experience
- Bracketing and worse case rating
- QC testing requirements
- Dirty hold times and clean hold times
Basic Qualifications:
- Experience utilizing Microsoft Word, Excel, and Outlook
- Experience writing and revising documents (e.g. testing methods, protocols, reports)
- Experience performing testing in a GMP setting
- MS Project experience
Skills
- Proficiency in utilizing documentation system to author protocols and reports
- Experience participating in teams and collaborative work environments.
- Good communication skills (verbal and written), math skills, general computer skills
- 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.
Education
- BS/MS in Science (e.g. Chemistry, Biochemistry, Analytical Chemistry) or Engineering (Chemical or Biochemical) with 2+ total years of experience working in a biologic, vaccine or pharma industry.
- Minimum 1-3 years validation experience
- No degree requirements but bonus if related.
MUST HAVE:
- cleaning validation experience
- strong communication skills
- ability to manage, execute and troubleshoot on their own
- Strong Microsoft Suite skills
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