USA-Principal Commissioning/Validation Engineer III (Engineering)

Virtual Company; Swiftwater (Monroe County); On-site; USD 94,000 - 134,000; Part time

Job summary

The Fountain Group is seeking a Commissioning/Validation Engineer for a prominent client in Swiftwater, PA. You will support pharmaceutical manufacturing operations, with a primary focus on Formulation and Filling, while partnering with Quality, Operations, Engineering, MSAT and Sterility Assurance to drive CAPA, Change Control, and regulatory compliance.

This 9-month assignment offers an $83/hour starting rate, with a standard 8–4:30 schedule, Monday–Friday, and opportunities to apply Lean, Six

Qualifications

• Bachelor’s degree required with 3–5 years of relevant experience in GMP/pharma/biotech environments.
• Experience with deviations, Quality Systems, continuous improvement and regulated GMP pharmaceutical or biotech manufacturing environments.
• Experience with digital manufacturing systems such as eBR, Opstrakker, MES or similar.

Responsibilities

• Provide dedicated support to pharmaceutical manufacturing operations, focusing on Formulation and Filling.
• Collaborate with Quality, Operations, Engineering, MSAT, Sterility Assurance and cross-functional teams to drive CAPA, Change Control and investigations.
• Support continuous improvement initiatives using Lean Manufacturing, Six Sigma and +QDCI Visual Management principles.

Skills

Deviations handling

Quality Systems

Continuous improvement

GMP

Education

Bachelor’s degree

3–5 years experience

Tools

eBR

Opstrakker

MES

Job description

We are a national staffing firm and are currently seeking a Commissioning/Validation Engineer for a prominent client of ours.

This position is located in Swiftwater, PA.

Details of the position are as follows:

Job Description:

• Pay is $83/hr to start!!
• 9 – month assignment
• 8 – 4:30; Monday – Friday
• Provide dedicated support to pharmaceutical manufacturing operations, with a primary focus on Formulation and Filling.
• This position will partner with Quality, Operations, Engineering, MSAT, Sterility Assurance, and other cross-functional teams to drive CAPA, Change Control, quality investigations, root cause analysis, and continuous improvement initiatives while maintaining compliance with cGMP and regulatory requirements.
• Support continuous improvement efforts utilizing Lean Manufacturing, Six Sigma, and +QDCI Visual Management principles.

Qualifications:

• Bachelor’s degree and 3–5 years of relevant experience
• Strong experience with deviations, Quality Systems, continuous improvement, and regulated GMP pharmaceutical or biotech manufacturing environments.
• Experience with eBR, Opstrakker, MES, or similar digital manufacturing systems.

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