Apply on Employer Site

Catalent · 1 day ago

Process Validation Engineer

Greenville, NC

Full-time

Onsite

Entry, Mid Level

2+ years exp

Catalent is a global, high-growth company and a leading partner for the pharmaceutical industry. The Process Validation Engineer provides direct validation support to pharmaceutical development and manufacturing operations, ensuring accurate execution and documentation of all activities and projects as assigned.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Collaborate with the Cleaning Verification and Validation Analytical Group to develop draft cleaning verification and validation protocols

Review cleaning validation protocols, residue limits, reports, and cleaning verification/validation summary packages

Evaluate the impact of planned and unplanned changes to formulations, processes, or equipment on cleaning validation status

Author and review equipment and utilities qualification protocols and summary reports

Review executed qualification protocols and summary reports for completeness, accuracy, and compliance

Assist with the execution of equipment and utilities qualification activities as required

Ensure validation documentation is archived in accordance with GMP documentation retention requirements

Qualification

Process validationCleaning validationPharmaceutical industry experienceEquipment qualificationTechnicalLife Sciences degree

Required

Bachelor's degree in a Technical or Life Sciences discipline with a minimum of two (2) years of experience in the pharmaceutical industry; or

Associate degree in a Technical or Life Sciences discipline with a minimum of four (4) years of experience in the pharmaceutical industry

Minimum of one (1) year of validation experience required

Preferred

Oral solid dosage (OSD) experience preferred

Process validation experience strongly preferred

Experience in a Catalent production role with a demonstrated solid understanding of internal manufacturing processes may be considered in lieu of direct validation experience

Benefits

Competitive medical benefits

401K

152 hours PTO + 8 Paid Holidays

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (1)