Validation Engineer (Cleaning Validation)

Job Description:

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.

Comment:

• Mainly Monday Friday with some flexibility in working hours.
• Will work some form of 8 hours within 7am and 5pm.
• Manager flexible. Prefer new hire to be open to very occasional weekend work or overtime if needed.
• May also need to switch a shift from morning to afternoon here and there.
• 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.
• Minimum 1-3 years validation experience, open to more experience within rate range.
• 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