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Sr Quality Engineer - Cleaning Validation - Ocean County, New Jersey

Azzur Group


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We are seeking a talented Quality Engineer for our life sciences client to perform duties associated with cleaning validation processes and monitoring of cleaning verification activities consistent with cGMP requirements for clinical manufacturing, scale-up and commercial manufacture of sterile and speciality pharmaceutical products. Specific duties include:

Perform laboratory experiments for rinse recovery studies and perform visual acuity testing to verify the ability to detect residual material..
Develop cleaning acceptance criteria and generate and execute cleaning development studies and cleaning verification / validation protocols.
Develop, update and maintain Cleaning Validation SOPs, batch records, procedures and other documentation/deliverables.
Generate and maintain a site cleaning validation program plan, including risk assessments and review procedures for cleaning production and packaging equipment.
Support Method Development activities, review Method Develop Documents and the selection of product markers to detect trace levels of drug product and drug substances.
Qualifications:

Engineering, Life Sciences or related degree and a minimum of three years related performing validation activities within an aseptic pharmaceutical environment; or equivalent combination of education and experience.

In-depth understanding of cGMP and FDA, ISO, EU and ICH related regulatory validation/quality policies, requirements, guidelines, standards, practices, etc.

Strong analytical, communication and computer skills to utilize software/systems and analyze problems, provide recommendations and develop plans for process/production improvements.

Effective interpersonal ability to work independently on projects and/or in team environment as required.

Should you be interested in finding out more about this exciting opportunity please contact Tony Roig, Talent Acquisition Manager, today. Our Client offers a state-of-the-art facility, positive work environment along with an attractive compensation/benefits package.
Primary Skills: Cleaning Validation
Sterile Aspectic
Salary: Between 75000 - 90000
Experience Required: Experienced, 3 years minimum
Clearance Level: none
Travel: 10 %

Other Details: Facility has State-of-the-art equipment; Employer offers career mobility/good benefit package


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