What are the responsibilities and job description for the Validation Specialist III (Cleaning Validation) position at Integrated Resources, Inc ( IRI )?
Job Title: Validation Specialist III
Location: Swiftwater, PA (Mostly hybrid - will usually be 4 days onsite and one remote but the manager prefers flexibility just in case they are needed onsite the extra day)
Duration: 12 months (Possibility of an extension)
Shift hours: Mainly M-F with some flexibility in working hours. 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.
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.
Job Description:
- Experience in cleaning validation in the biologics or vaccine industry.
- 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.
- 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, open to more experience within rate range.
Salary : $77 - $82
