Top 13 Fermentation Jobs in Alameda, Ca

Validation Engineer
InfoQuest Consulting Group Inc. —Emeryville, CA
- Email
- Mid-level
- Team management
- Mentoring
Research Associate I (Protein Science & Analytics)
EVERY™ —San Francisco Bay Area, CA
- $75,000 - $85,000 a year
- Analysis skills
- Bachelor's degree
- US work authorization
- Free parking
- Paid holidays
Quick Apply
4d
Metabolic Engineering Research Associate I
Recombia Biosciences, Inc. —Brisbane, CA
- $62,000 - $75,000 a year
- Bachelor's degree
- 1 year
- Communication skills
- Paid holidays
- Dental insurance
Quick Apply
Food /Protein Chemistry Scientist
Just Food Company —Emeryville, CA
- $135,000 - $158,000 a year
- Full-time
- Master's degree
- Analysis skills
- Doctor of Philosophy
- Health insurance
- Dental insurance
Quick Apply
4d
Life Science Research Professional 1
Stanford University —Stanford, CA
- $32.87 - $40.52 an hour
- Full-time
- Computer literacy
- Maintenance
- Mid-level
9h
General Production Labor Kitchen -1st Shift - (Heavy Lifting Required)
Tyson Foods —San Lorenzo, CA
- From $23 an hour
- Overtime
- Background check
- Heavy lifting
- Ability to walk for extended periods
- Dental insurance
- 401(k)
Senior Scientist
Corbion —South San Francisco, CA
- $130,000 - $150,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Business development
- Paid holidays
- Disability insurance
Lead Brewer - Temporary/Part-Time Position
Residential and Dining Enterprises at Stanford University —Stanford, CA
- $28 - $34 an hour
- Temporary
- Hospitality
- Bar
- Mid-level
- Health insurance
- Tuition reimbursement
Quick Apply
Director of Bioengineering (Recombia)
Recombia Biosciences, Inc. —Brisbane, CA
- $190,000 - $280,000 a year
- 11+ years
- Business development
- Doctor of Philosophy
- Paid holidays
- Dental insurance
Quick Apply
3d
Process Engineer
BioMADE —Hayward, CA
- $120,000 - $150,000 a year
- Full-time
- Hybrid work
- 5 years
- Mid-level
- Master's degree
- Free parking
- Commuter assistance
Quick Apply
11h
Scientist II, Upstream Development for Protein Development and Manufacturing
Vaxcyte —San Carlos, CA
- $146,000 - $171,000 a year
- Bachelor of Science
- Mid-level
- Bachelor's degree
Brewer
Mare Island Brewing Co. —Vallejo, CA
- $20 - $25 an hour
- Full-time
- Computer literacy
- Laboratory experience
- Mid-level
- Health insurance
- 401(k)
Quick Apply

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Research Associate I (Protein Science & Analytics)
EVERY™ —San Francisco Bay Area, CA
Bachelor's Degree in Biology, Biochemistry, Chemistry, or a related field. This unique entry-level Research Associate I position offers the rare chance to work…
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Senior Associate Scientist/Scientist I, Protein Sciences
ImmunEdge, Inc —Redwood City, CA
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fermentation jobs near alameda, ca

Validation Engineer

InfoQuest Consulting Group Inc.
Emeryville, CA

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Job Details

Contract

Qualifications

Statistics
Mechanical blueprint interpretation
Process flow diagrams
Compliance risk assessment
Technical documentation
Interpreting technical drawings
SIP (Steam-in-Place)
GMP
Piping and instrumentation diagrams (P&IDs)
Minitab
Manufacturing facility experience
Production validation processes
Quality risk management
Compliance documentation
Bioprocessing
Biomedical regulatory compliance
Regulatory compliance analysis
Achieving project delivery timelines
CIP (Clean-in-Place)
Data analysis software
Pharmaceutical manufacturing facility experience

Full Job Description

Duration & Type: 6+ months Contract with a major pharmaceutical industry client

Location: Emeryville, CA 94608 – 100% Onsite

Responsibilities:

The Validation Engineer supports validation activities related to facility, manufacturing process, cleaning process, equipment and computer validation
These will encompass new facility/equipment/process, process and equipment changes, and periodic requalification/revalidation.
Prepares validation plans, protocols, test scripts and reports throughout all stages of validation lifecycle.
Be responsible for coordination and execution of validation activities and be expected to play a key role in developing and driving risk based validation approach during essential stages of product lifecycle including process design/control strategy development, technology transfer, equipment/utilities commissioning & qualification (C&Q), process performance qualification (PPQ), continued process verification (CPV), process control/risk management, and product decommissioning.
Perform qualification of manufacturing equipment, facility and utility systems (including CIP/SIP qualification), cleaning validation, and process validation. Scope of responsibilities includes drafting of qualification protocols and summary reports, field execution, and data analysis.
As needed coordinate and provide directions to contract personnel performing validation activities.
Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.
Support the development and update of validation master plans, validation project plans, SOPs, risk assessments, user requirements, cleaning assessments, technical assessment reports.
Support cleaning and sterilization (including CIP/SIP, manual cleaning, steam sterilization, and dry heat depyrogenation) development activities.
Support periodic requalification and revalidation effort.
Work independently and directly interface with personnel from multiple departments including Technical
Development, Manufacturing, Engineering, Manufacturing Support, MAC, QC, and QA.
Support gap assessment/closure, corrective actions, and compliance remediation related to Validation.
As needed, represent Validation as SME (Subject Matter Expert) during regulatory or customer inspections.
As assigned mentor and manage full time validation engineers/specialist and contractors.

Required:

Expertise in the following areas is must: Facility/Equipment/Utility Qualification, Cleaning/Sterilization Cycle Development, Cleaning Validation, and Process Validation.
Familiar with applicable domestic and international GMP regulations impacting validation requirements (e.g. 21 CFR 210).
Familiar with current industry guidance documents impacting validation best practices (e.g. FDA Process Validation guidance, ISO 13485, ISO 14971, ASTM E2500, and applicable PDA Technical Reports).
Experience with customer and regulatory inspection.
Strong understanding of quality risk management principles, including best practice in risk based C&Q approach.
Hands on validation experience in developing validation documentation and field execution.
Familiarity & demonstrated knowledge of biologics manufacturing processes, including fermentation, purification & bulk filling processes.
Ability to work independently in a matrix team environment, influence team decisions, exercise sound judgement in determining compliant & robust validation approach.
Ability to multi-task with demonstrated track records in meeting deliverable timelines.
Must demonstrate the ability to think critically & analytically with acumen for trouble-shooting & problem solving.
Good interpersonal skills, accountable with excellent verbal & written communication skills.
Ability to function effectively & independently in a fast-paced & dynamic environment.
Self-motivated & willing to tackle assignments & development opportunities outside of job scope.
Ability to interpret engineering & facility drawings such as facility layouts, blueprints, material/process flow diagrams & equipment P&IDs.
Understanding of basic statistics, acceptance sampling & familiar with statistics software such as Minitab & JMP
Strong team player aligned with Grifols Corporate Values.
Hands on experience with facility/equipment/utility qualification, cleaning validation, process validation & sterilization validation (steam sterilization & dry heat Depyrogenation) in GMP environment is required.
Hands on experience with CIP/SIP cycle development & qualification is required.
Hands-on engineer.

For consideration, please send resume to [email protected]

Apply Now

Refine Your Search

fermentation jobs in alameda, ca

Validation Engineer

Research Associate I (Protein Science & Analytics)

Metabolic Engineering Research Associate I

Food /Protein Chemistry Scientist

Life Science Research Professional 1

General Production Labor Kitchen -1st Shift - (Heavy Lifting Required)

Senior Scientist

Lead Brewer - Temporary/Part-Time Position

Director of Bioengineering (Recombia)

Process Engineer

Scientist II, Upstream Development for Protein Development and Manufacturing

Brewer

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