Senior Manufacturing Associate I (Swing Shift - 1pm - 9:30pm) *PC 567

Miltenyi Biotec; San Jose (CA); On-site; USD 67,000 - 78,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

401(k) plan

Bonus potential

Job summary

Miltenyi Biotec is seeking an operator for biologics manufacturing under cGMP conditions in a San Jose, CA facility. You will follow established procedures, execute batch records, and support training and documentation while working in a cleanroom environment.

The role requires 2+ years of GMP/aseptic experience, strong communication, and proficiency with MS Excel for data trends. Swing shift 1:00 pm–9:30 pm, Mon–Fri, with comprehensive benefits.

Qualifications

• High School diploma or equivalent.
• 2+ years of related experience in GMP/aseptic environments preferred.
• Ability to follow SOPs and gowning procedures.
• Excellent verbal and written communication skills; attention to detail.

Responsibilities

• Adhere to clean room SOPs for gowning and workflow.
• Support production schedules and ensure equipment/materials availability.
• Execute batch records and GMP documentation; review for accuracy.
• Assist investigations and corrective actions with manufacturing leads.
• Contribute to writing SOPs, MSs, SMPs, BPRs and other GMP docs.
• Maintain equipment cleanliness and proper maintenance under cGMPs.

Skills

Effective communication

GMP aseptic understanding

Documentation skills

Computer literacy

Problem solving

Education

High School diploma

Tools

MS Excel

Job description

Your Role:

This position is responsible for manufacture of biologics under cGMP conditions. Staff must follow established procedures, execute batch production records using good documentation practices and adhere to gowning procedures required for work in cleanroom environment. Support training new hires, trouble shooting, preparation of controlled documentation and other Manufacturing duties.

Essential Duties and Responsibilities:

• Adhere to clean room Standard Operational Procedures (SOPs) for gowning, traffic flows, modes of operation.
• Support manufacturing / production schedules, ensures equipment are available / released for use, maintains manufacturing materials supply to support operations and perform process set up, operations and process monitoring.
• Execute batch record instructions, Standard Operating Procedures, complete GMP documentation and assist in reviewing executed batch records for completeness and accuracy.
• Assist Manufacturing team Leads in Investigations and corrective actions as required.
• Contribute to the development, writing, and review of Standard Operating Procedures (SOPs), Material Specifications (MSs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation.
• Responsible for cleaning, proper maintenance and use of production equipment in strict accordance with cGMPs, SOPs and safety policies.
• Ensure and maintain inventory and restock supplies when needed. Assist in troubleshooting processing issues, support investigation and establish root cause and resolution/corrective action.
• Collect, trend and analyze process data using MS Excel.
• Swing Shift Schedule: 1:00 pm to 9:30 pm, Monday thru Friday

Requirements:

• Completion of High School; 2+ years of related experience.
• Previous GMP and aseptic technique experience is desired.

Skills:

• Ability to articulate production equipment and / or manufacturing process problems to ensure accurate and detailed communication.
• Able to provide detailed communication to multiple departments.
• Excellent computer skills, verbal and written communication skills at all levels.
• Must have Quality and safety mindset and fast learner.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to cultured human cells (immortalized, not primary) and lentivirus-derived vector particles. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, glasses and gloves. The noise level in the work environment is usually moderate.

The anticipated base salary range has been established at $66,686 ($32.06/hr) - $78,358 ($37.67/hr)/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.

Miltenyi Biotec is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.