Collaborate daily with Engineering, Quality, Automation, Manufacturing, and client stakeholders ... Experience: * 0-2 years of hands-on CQV experience in pharmaceutical, biotechnology, and/or medical ...
Collaborate daily with Engineering, Quality, Automation, Manufacturing, and client stakeholders ... Experience: * 0-2 years of hands-on CQV experience in pharmaceutical, biotechnology, and/or medical ...
Since 1980,we'vehelped pioneer the world of biotech in our fight against the world's toughest ... manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Since 1980,we'vehelped pioneer the world of biotech in our fight against the world's toughest ... manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest ... manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest ... manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest ... manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest ... manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest ... we research, manufacture, and deliver innovative medicines to help people live longer, fuller ...
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest ... we research, manufacture, and deliver innovative medicines to help people live longer, fuller ...
Biotech Manufacturing Associate information
See Racine, WI salary details
$11.50 - $13.30
5% of jobs
$13.30 - $15.10
17% of jobs
$15.32 is the 25th percentile. Wages below this are outliers.
$15.10 - $16.91
24% of jobs
The median wage is $17.28 / hr.
$16.91 - $18.71
18% of jobs
$18.71 - $20.51
9% of jobs
$20.83 is the 75th percentile. Wages above this are outliers.
$20.51 - $22.32
7% of jobs
$22.32 - $24.12
3% of jobs
$24.12 - $25.92
3% of jobs
$25.92 - $27.72
3% of jobs
$27.72 - $29.53
5% of jobs
$29.53 - $31.33
4% of jobs
$11
$19
$31
How much do biotech manufacturing associate jobs pay per hour?
What are the key skills and qualifications needed to thrive as a Biotech Manufacturing Associate, and why are they important?
What are some common challenges faced by Biotech Manufacturing Associates, and how can they be managed effectively?
What are Biotech Manufacturing Associates?
What is the highest paying job in biotech?
What is the difference between Biotech Manufacturing Associate vs Laboratory Technician?
| Aspect | Biotech Manufacturing Associate | Laboratory Technician |
|---|---|---|
| Credentials | High school diploma or equivalent; some roles may require associate degree | High school diploma or equivalent; some roles may require associate degree or certification |
| Work Environment | Manufacturing floor, production lines, cleanrooms | Laboratories, research facilities, testing environments |
| Industry Usage | Biotech manufacturing, pharmaceutical production | Research labs, quality control, testing labs |
While both roles support biotech operations, a Biotech Manufacturing Associate primarily works on production and manufacturing processes in a cleanroom environment, focusing on assembling, monitoring, and maintaining manufacturing equipment. In contrast, a Laboratory Technician typically conducts experiments, tests, and quality control procedures in a laboratory setting. Both roles require attention to detail and adherence to safety protocols, but their daily tasks and work environments differ significantly.

Job description
- Author, execute, and summarize commissioning and qualification deliverables including FAT/SAT, IQ, OQ, PQ protocols and reports for process equipment, clean utilities (WFI, clean steam, gases), HVAC/cleanrooms, and automated systems.
- Apply risk-based CQV approach in accordance with ASTM E2500, ICH Q9, and ISPE Baseline Guides.
- Perform field execution: system walkdowns, punch-list resolution, functional testing, loop checks, and startup support.
- Generate, investigate, and resolve deviations; support change control and CAPA processes in electronic quality systems.
- Author traceability matrices linking URS critical aspects testing.
- Collaborate daily with Engineering, Quality, Automation, Manufacturing, and client stakeholders.
- Provide technical input during design reviews and risk assessments (FMEA, PHA).
- Support validation maintenance activities (periodic review, re-qualification, change control impact assessments).
- Lead small to medium subsystems or work packages under guidance of a senior CQV lead.
- 0-2 years of hands-on CQV experience in pharmaceutical, biotechnology, and/or medical device industries
- Direct experience executing IOQ/PQ on automated equipment (filling lines, isolators, lyophilizers, device assembly equipment strongly preferred)
- Proven ability to author and execute qualification protocols independently
- Strong working knowledge of cGMP (21 CFR 210/211, Part 11, EU Annex 11), ASTM E2500, GAMP 5, and ISPE guidelinesExperience with electronic documentation and quality management systems
- Excellent technical writing, organization, and communication skills
- Proven ability to develop validation strategy independently
- Detail-oriented
- Highly organized
- Excellent written and oral English communication skills
- Excellent problem-solving skills
- Seasoned soft skills
- Team player
- IT and technology savvy
- Understanding of FDA's CGMPs (i.e., Quality Systems)
About Kymanox
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Morrisville, NC, US
Year founded
2004