USA-Validation Specialist III

Industry: Biotechnology

Title: Validation Specialist III

Job ID: SNFIJP(phone number removed)

Location: Swiftwater, PA (Hybrid)

Duration: 12 months (+Possibilities of extension)

THIS IS A CLEANING VALIDATION POSITION.

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

Notes from the Manager:

Mainly M-F with some flexibility in working hours. Will work some form of 8 hours within 7am and 5pm. 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: 1. cleaning validation experience 2. strong communication skills 3. ability to manage, execute and troubleshoot on their own 4. Strong Microsoft Suite skills

PH EN