Be an early applicantLess than 25 applicantsPosted by Agency

Company

Original Job Post

Sharp Decisions · 3 days ago

Process Engineer I - Manufacturing Investigations

Frederick, MD

Contract

Onsite

Mid Level

2+ years exp

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B2BHuman Resources

H1B Sponsorship

Senior Management

Hiring Manager

Sarthak saxena

Insider Connection @Sharp Decisions

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements.

Initiate quality records in the Veeva Quality Management System (QMS).

Lead cross-function team meetings to perform complex root cause analysis (RCA).

Compile investigation results in a concise and comprehensive technical report format.

Collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA).

Manage investigation timelines to meet/exceed site compliance metrics for closure adherence.

Provide timely progress updates to internal stakeholders, as required.

Qualification

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Biochemical EngineeringChemical EngineeringBiotechnologyChemistryBiology6 years relevant experienceTechnical writingRoot cause analysisCell cultureAseptic processingCGMPManufacturingOrganizationProblem-solving

Required

BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience

AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 years of relevant experience

HS Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent

Preferred

Strong skill in technical writing

Strong skill in organization

Strong skill in root cause analysis

Experience in cell culture or aseptic processing

Experience in cGMP cell therapy manufacturing

Company

Sharp Decisions

Sharp Decisions is a staffing and recruiting company that offers technology and business staffing solutions.

Founded in 1990

New York, New York, USA

201-500 employees

http://sharpdecisions.com

H1B Sponsorship

Sharp Decisions 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

Trends of Total Sponsorships

2023 (1)

2022 (8)

2021 (9)

2020 (9)