88-50100317 Manufacturing Engineer

Roche; South San Francisco (CA); In loco; USD 118.000 - 169.000; Tempo pieno

Descrizione del lavoro

Genentech, Inc. in South San Francisco, CA seeks a Manufacturing Engineer to support equipment troubleshooting for drug substance release and to lead projects that optimize production methods.

The role covers safety improvements, GMP campaign support, and collaboration with vendors and customer groups. A Bachelor's in Engineering with 3 years' experience is required; a discretionary annual bonus may apply.

Competenze

• Quality systems experience.
• Technical writing for commenting on QRM exceptions and process deviations.
• Experience with Operating Laboratory Inventory Management systems (LIMS).
• Upstream cell culture knowledge.
• Experience implementing novel techniques in cross-functional teams.

Mansioni

• Support troubleshooting on equipment for drug substance release.
• Lead projects to implement or optimize novel production methods.
• Improve facility/process safety through equipment upgrades.
• Support drug substance manufacturing from cell bank thaw to bulk freeze.
• Present data-driven information to stakeholders to influence decisions.

Conoscenze

Quality systems

Technical writing

Upstream cell culture

Project implementation

Formazione

Bachelor’s degree in Engineering

Strumenti

LIMS

Descrizione del lavoro

The Position

Genentech, Inc. seeks a Manufacturing Engineer at its South San Francisco, CA location.

Duties: As part of the Operations, Process Support and Process Engineering team, support troubleshooting efforts on equipment in support of release of drug substance materials. Initiate and lead projects that results in implementation and/or optimization of novel methods and techniques for drug substance production. Enhance safety of the organization through facility process/equipment improvements. Support the entire process for manufacturing investigational medicinal products of the drug substance from initial cell bank thaw through bulk freeze. Support drug substance manufacturing operations upstream and downstream. Responsible for technical evaluations and troubleshooting. Work with vendors on equipment or consumable design. Engage with customer groups, network teams and vendors seeking opportunities for collaboration, proactively communicating and presenting information and offering relevant data driven information to impact decisions. Execute daily floor operations during clinical Good Manufacturing Practice (GMP) campaigns. Give speaker presentations across departments within Genentech/Roche network.

Education and Experience Requirement: Requires a Bachelor’s degree, or foreign equivalent, in Engineering or related field and 3 years of experience in job offered or related engineering or laboratory role.

Specials Skills Requirement: Professional experience or academic knowledge must include:

1. Quality systems
2. Technical writing skills for commenting on QRM exceptions and process deviations
3. Operating Laboratory Inventory Management systems (LIMS)
4. Upstream Cell Culture
5. Project Implementation of Novel Techniques in cross-functional team

#LI-DNI #DNI #DE-DNI

Worksite: 1 DNA Way, South San Francisco CA, 94080

The expected annual salary range for this position based on the primary location for this position of South San Francisco, California is $117,624 to $168,500 per year. Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash )

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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