31 applicants

Company

CLA (CliftonLarsonAllen) · 1 day ago

Process Engineer: Isolator Technical Specialist

California, United States

Full-time

Remote

Mid Level

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AccountingConsulting

Growth Opportunities

H1B Sponsor Likely

Hiring Manager

LeAnn Cantwell

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Responsibilities

Execute isolator cycle development, qualification, and re-qualification

Ability to follow SOPs follow instructions, with attention to detail and final report generation.

Have good written and verbal communication skills.

Have a strong customer focus.

Carry out the work in an accurate, independent manner.

Duties, responsibilities, and activities may change at any time, with or without notice.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

H2O2 decontaminationQC Microbiology Lab operationsCGMP StandardsFDA guidanceEU guidanceBiological indicatorsSterility testingProcess engineeringManagement experienceProject management

Required

Bachelor’s degree in Engineering, Life Sciences, or a related field.

Relevant process engineer experience or experience in plant qualification/validation in special machine construction or the GMP area.

Ability to follow SOPs follow instructions, with attention to detail and final report generation.

Have good written and verbal communication skills.

Have a strong customer focus.

Carry out the work in an accurate, independent manner.

Effective communication and interpersonal skills.

Ability to manage multiple projects and meet deadlines.

Preferred

Management experience preferred

Knowledge and technical expertise related to H2O2 decontamination, QC Microbiology Lab operations, cGMP Standards, OSHA requirements, FDA and EU guidance related to aseptic production, USP and EP standards related to biological indicators, and sterility testing are all desirable.

Company

CLA (CliftonLarsonAllen)

Glassdoor

3.9

CLA exists to create opportunities for our clients, our people, and our communities through industry-focused wealth advisory, outsourcing, audit, tax, and consulting services.

Founded in 1960

Minneapolis, Minnesota, USA

5001-10000 employees

http://www.claconnect.com

H1B Sponsorship

CLA (CliftonLarsonAllen) 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

2023 (1)

2022 (3)

2021 (2)

2020 (1)