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Validation Specialist III
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Pyramid Consulting Swiftwater, United StatesImmediate need for a talented · Validation Specialist III (Engineering). · This is a · 12+ months Contract · opportunity with long-term potential and is located in · Swiftwater, PA(Onsite). · Please review the job description below and contact me ASAP if you are interested. ...
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Validation Specialist III
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Validation Specialist III
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Validation Specialist III - Swiftwater, United States - Aequor
Description
Validation Specialist III
Location: Swiftwater, PA (Hybrid)
Duration: Contract till March 2025 with possibility to extend
Only W2
THIS IS A CLEANING VALIDATION POSITION.
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. Minimum 1-3 years validation experience, open to more experience within rate range. No degree requirements but bonus if related. MUST HAVE: 1. cleaning validation experience 2. strong communication skills 3. ability to manage, execute and troubleshoot on their own 4. Strong Microsoft Suite skills
Duties
________________________________________
• 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
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
Please contact me if you are interested. Thank you.
Thank You,
Gurpreet Kaur
Aequor Technologies LLC
377 Hoes Lane, Suite 300
Piscataway, NJ 08854
