Cleaning Validation Specialist

Spectraforce

Swiftwater, Pennsylvania


a month ago

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Job Description

Cleaning Validation Specialist
Swiftwater, PA, 18370
12 months


Notes by Hiring Manager:
  • Mainly M-F 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:
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 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $72.00/hr.