Senior Validation Engineer

Modis; Swiftwater (Monroe County); On-site; USD 83,000 - 110,000; Full time

Job summary

Modis is seeking a Validation Engineer III for a contract role in Swiftwater, PA. The ideal candidate has solid pharma/biotech QA exposure and hands-on work with regulatory compliance.

The role focuses on cGMP operations, validation activities across formulation, filling, lyophilization, and investigations, and management of CAPAs and change controls. A Bachelor's degree and 3–5 years of relevant experience are required.

Qualifications

• Bachelor's degree required with 3–5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
• Experience with formulation, filling, lyophilization, and/or inspection processes.
• Experience managing CAPAs, Change Controls, quality investigations, and root cause analysis.

Responsibilities

• Bachelor's degree required with minimum 3-5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
• Experience with formulation, filling, lyophilization, and/or inspection processes.
• Experience managing CAPAs, Change Controls, quality investigations, and root cause analysis.

Skills

Validation

Pharma/Biotech

cGMP

Quality Systems

Continuous Improvement

Education

Bachelors degree

Tools

iShift

Qualipso

eBR

Opstrakker

Job description

Modis is seeking a Validation Engineer III for a Contract job with a client in Swiftwater, PA. Ideally looking for applicants with a solid background in the Pharmaceutical or Biotech Industry.

Rate Range : $60 - $80/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Job responsibilities include:

• Bachelors degree required with minimum 3-5 years of relevant experience in pharmaceutical manufacturing, Quality Systems, Continuous Improvement, or a related regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical manufacturing operations.
• Experience with formulation, filling, lyophilization, and/or inspection processes.
• Experience managing CAPAs, Change Controls, quality investigations, and root cause analysis.

Desired Qualifications:

• Knowledge of Lean Manufacturing and Six Sigma methodologies.
• Strong technical writing, project management, problem-solving, and cross-functional communication skills.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Experience with iShift, Qualipso, eBR, and Opstrakker preferred.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers