H-1B Visa Manufacturing Associate Jobs
Manufacturing Associate roles can qualify for H-1B sponsorship when the position requires a bachelor's degree in engineering, industrial technology, or a directly related field. Employers in automotive, aerospace, pharmaceuticals, and electronics regularly file LCAs for these roles. Prevailing wage compliance and specialty occupation documentation are the two factors that determine whether your offer converts to a petition.
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Get Access To All JobsAbout the Company:
Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
Job Location:
Nivagen Pharmaceuticals LLC, Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834
About the Job:
Title of the Position: Manufacturing Associate
The Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs. This role plays a critical part in ensuring the integrity and quality of sterile drug products manufactured at Nivagen. The position requires a high degree of attention to detail, adherence to gowning and aseptic techniques, and the ability to follow precise procedures.
Responsibilities:
- Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection.
- Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions.
- Comply with all gowning requirements and environmental control procedures to maintain sterile conditions.
- Follow batch production records (BPRs), standard operating procedures (SOPs), and material handling protocols.
- Support execution of media fills, process validations, and cleanroom qualification activities.
- Participate in room and equipment sanitization activities, ensuring compliance with established cleaning frequencies.
- Complete all training in a timely manner and maintain qualification for aseptic operations.
- Accurately record all activities in cGMP documentation, ensuring data integrity.
- Assist with investigations, deviations, CAPAs, and continuous improvement initiatives.
- Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs.
- Follow safety, health, and environmental policies and procedures.
Qualifications
Education/Experience:
- High School diploma or GED required; Associate's or Bachelor's degree in Life Sciences or related field preferred.
- Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred.
- Experience in cGMP-regulated environments is highly desirable.
Knowledge, Skills, and Abilities:
- Strong understanding of aseptic technique, cleanroom behavior, and contamination control.
- Ability to read and follow SOPs, batch records, and manufacturing instructions precisely.
- Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods.
- Detail-oriented with strong documentation and communication skills.
- Ability to work independently and as part of a collaborative team.
- Willingness to work flexible shifts and weekends as required by the production schedule.
Requirements
- Valid driver's license and acceptable driving record.
- Legally authorized to be employed in the United States.
- This role is an on-site role and requires daily commuting to and from the facility.
- This role requires work in a controlled cleanroom environment with strict gowning and hygiene protocols.
- Must be able to stand for extended periods, lift up to 50 pounds, and perform repetitive tasks.
Benefits:
- Fulltime Employment
- $28 - $32 per hour
- Annual Bonus eligibility
- Medical, Dental, and Vision coverage
- PTO plan
- 401K plan
Nivagen Pharmaceuticals affords equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
About the Company:
Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
Job Location:
Nivagen Pharmaceuticals LLC, Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834
About the Job:
Title of the Position: Manufacturing Associate
The Manufacturing Associate is responsible for executing aseptic and cleanroom manufacturing operations in compliance with cGMP, regulatory standards, and internal SOPs. This role plays a critical part in ensuring the integrity and quality of sterile drug products manufactured at Nivagen. The position requires a high degree of attention to detail, adherence to gowning and aseptic techniques, and the ability to follow precise procedures.
Responsibilities:
- Perform aseptic manufacturing operations in Grade A, B, C, and D cleanroom environments, including formulation, filtration, filling, and visual inspection.
- Set up, operate, and clean equipment such as vial/syringe fillers, autoclaves, and isolators under sterile conditions.
- Comply with all gowning requirements and environmental control procedures to maintain sterile conditions.
- Follow batch production records (BPRs), standard operating procedures (SOPs), and material handling protocols.
- Support execution of media fills, process validations, and cleanroom qualification activities.
- Participate in room and equipment sanitization activities, ensuring compliance with established cleaning frequencies.
- Complete all training in a timely manner and maintain qualification for aseptic operations.
- Accurately record all activities in cGMP documentation, ensuring data integrity.
- Assist with investigations, deviations, CAPAs, and continuous improvement initiatives.
- Collaborate with Quality, Validation, Engineering, and Tech Services as needed to ensure successful production runs.
- Follow safety, health, and environmental policies and procedures.
Qualifications
Education/Experience:
- High School diploma or GED required; Associate's or Bachelor's degree in Life Sciences or related field preferred.
- Experience in an aseptic or sterile pharmaceutical manufacturing environment preferred.
- Experience in cGMP-regulated environments is highly desirable.
Knowledge, Skills, and Abilities:
- Strong understanding of aseptic technique, cleanroom behavior, and contamination control.
- Ability to read and follow SOPs, batch records, and manufacturing instructions precisely.
- Comfortable wearing full aseptic gowning (hoods, coveralls, gloves, booties, masks) for extended periods.
- Detail-oriented with strong documentation and communication skills.
- Ability to work independently and as part of a collaborative team.
- Willingness to work flexible shifts and weekends as required by the production schedule.
Requirements
- Valid driver's license and acceptable driving record.
- Legally authorized to be employed in the United States.
- This role is an on-site role and requires daily commuting to and from the facility.
- This role requires work in a controlled cleanroom environment with strict gowning and hygiene protocols.
- Must be able to stand for extended periods, lift up to 50 pounds, and perform repetitive tasks.
Benefits:
- Fulltime Employment
- $28 - $32 per hour
- Annual Bonus eligibility
- Medical, Dental, and Vision coverage
- PTO plan
- 401K plan
Nivagen Pharmaceuticals affords equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
See all 4,300+ Manufacturing Associate jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Manufacturing Associate
Verify your role meets specialty occupation
Pull the O*NET profile for Manufacturing Associate and confirm the job description explicitly requires a bachelor's degree in a specific field. Positions listed as 'degree preferred' rather than 'required' can trigger a USCIS Request for Evidence.
Check prevailing wage before accepting an offer
Run the SOC code for your role through the OFLC Wage Search before signing anything. Your offered wage must meet at least the Level 1 prevailing wage for your work location, or the LCA certification will fail.
Target employers with active LCA filing history
Use Migrate Mate to filter Manufacturing Associate roles by employers who have certified LCAs for this occupation. That filing history confirms the employer understands the H-1B process for production and operations roles.
Prioritize E-Verify enrolled manufacturers
Ask recruiters whether the facility is E-Verify enrolled before advancing to an offer. STEM OPT extensions and cap-gap protections both require E-Verify enrollment, so this affects your authorization timeline if you're transitioning from F-1 status.
Understand cap-exempt employer options
Manufacturing roles at universities, affiliated research institutions, or nonprofit research organizations are cap-exempt, bypassing the annual lottery entirely. If you're at risk of going unselected, these employers let your employer file any time of year.
Document your degree equivalency for three-year programs
If your engineering or technology degree is a three-year program from outside the U.S., get a credential evaluation from a NACES-member agency before your employer files the I-129. USCIS scrutinizes three-year degrees heavily for specialty occupation petitions.
Manufacturing Associate jobs are hiring across the US. Find yours.
Find Manufacturing Associate JobsManufacturing Associate H-1B Visa: Frequently Asked Questions
Does a Manufacturing Associate role qualify as a specialty occupation for H-1B purposes?
It depends on how the position is defined. USCIS evaluates whether the role normally requires at least a bachelor's degree in a specific field like industrial engineering, manufacturing engineering, or materials science. Generic production roles without a degree requirement won't qualify. Roles in pharmaceuticals, aerospace, or semiconductor manufacturing that require engineering credentials typically do meet the standard.
How do I find Manufacturing Associate employers who sponsor H-1B visas?
Migrate Mate filters Manufacturing Associate openings by employers with verified LCA filing history, so you're only seeing companies that have already gone through the H-1B process for this type of role. That's a faster signal than asking a recruiter directly, since LCA certifications are public DOL records tied to specific job titles and work locations.
What SOC code is typically used for Manufacturing Associate H-1B petitions?
Most employers file under SOC 17-2112 (Industrial Engineers) or 51-9199 (Production Workers, All Other), depending on the role's actual duties. The SOC code determines the prevailing wage tier, so a misclassified code can result in an underpaid offer that fails LCA certification. Confirm the SOC code with your employer before the LCA is filed.
Can I switch Manufacturing Associate employers while on H-1B status?
Yes, H-1B portability under AC21 lets you start working for a new employer once they file a new I-129 petition, as long as your original petition has been approved and you've been in valid H-1B status for at least 180 days. Your new employer must file before your current status expires, and the new role must still qualify as a specialty occupation.
What documentation does a Manufacturing Associate need for an H-1B petition?
You'll need your degree transcripts and diploma, a credential evaluation if your degree is from outside the U.S., and your current resume showing relevant work history. Your employer supplies the LCA, a support letter explaining why the role requires your specific degree, and any professional licenses required in your state. USCIS may also request detailed job duty descriptions as part of the specialty occupation analysis.
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