Validation Specialist III - BH7581
Job description
Job Title: Validation Specialist III
Location: Swiftwater, PA. Onsite, 4 days a week most likely.
Duration: 8+ Months
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
TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Job Types: Contract, Temporary
Pay: Up to $78.00 per hour
Benefits:
- Dental insurance
- Health insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Education:
- Bachelor's (Required)
Experience:
- Cleaning validation (CV): 1 year (Preferred)
- pharma: 1 year (Required)
- bio pharma: 1 year (Required)
- root cause analysis with cGMP: 1 year (Required)
Work Location: In person
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