MSAT Process Engineer II *PC 522

Miltenyi Biotec, Inc.; San Jose (CA); On-site; USD 121,000 - 142,000; Full time

Job summary

Miltenyi Biotec, Inc. is seeking a Process Engineer II, MSAT to support technology transfer and manufacturing operations in a GMP biologics setting.

You will join the MSAT team, collaborating with Process Development, QA, QC, Validation, and Manufacturing to ensure robust, compliant processes and effective tech transfers. The role emphasizes troubleshooting, data analysis, and lifecycle management of processes including scale-up and supplier qualification, with cross-functional teamwork and

Qualifications

• Bachelor’s degree in science with 5+ years of progressive GMP biologics manufacturing experience.
• Or Master’s in science/chemical engineering with 3+ years in biologics/gene therapy manufacturing, MS&T or related roles; 5+ years GMP experience.

Responsibilities

• Assist technology transfer activities from development to manufacturing.
• Manage/Support timely completion of manufacturing quality events (deviations, investigations, CAPAs, change controls).
• Coordinate development, writing, review of SOPs, SMPs, BPRs and other GMP docs.
• Investigate and troubleshoot process deviations and equipment issues.
• Lead root cause investigations and CAPA implementation.
• Assist design/execute process validation and qualification docs (e.g., PPQ).
• Analyze process data to identify trends and drive improvements.

Skills

Communication skills

Project management

Analytical thinking

Team player

Cross-functional collaboration

Education

Bachelor’s degree in related science

Master’s in science/engineering (optional)

Tools

JMP

Microsoft Office

Job description

This position is in the Manufacturing Science and Technology team (MS&T) team. The Process Engineer II, MSAT is responsible for providing technical support to manufacturing operations, ensuring robust, efficient, and compliant production processes. This role is a key interface between internal (Process Development) / external (Clients) and Manufacturing, with a focus on technology transfer, process optimization, and troubleshooting.

This position is responsible for assisting Technology Transfer (TT) of processes, authoring of technical documentation, risk assessments, implementation of GMP documentation (batch records and SOPs) and managing manufacturing related quality events (change controls, deviations, CAPAs) and investigations.

Additionally, this position will collaborate closely with internal and external stakeholders establishing partnerships to ensure compliance with cGMP and Quality Management systems to deliver our services to the clients effectively.

Essential Duties and Responsibilities:

• Assist in technology transfer activities from process development to manufacturing, including preparation of documentation and support during execution.
• Manages/Support timely completion of Manufacturing related Quality Events (QEs) such as deviations, investigations, CAPAs, and Change Controls.
• Coordinate the development, writing, collaboration and review of Standard Operating Procedures (SOPs), Standard Manufacturing Procedures (SMPs), Batch Production Records (BPRs) and other GMP documentation.
• Investigate and troubleshoot process deviations, non-conformances, and equipment issues.
• Participate in or lead root cause investigations and implement CAPAs.
• Assist design and execution of process validation and qualification documentation (e.g., PPQ).
• Analyze process data to identify trends, drive improvements, and ensure control strategies are effective.
• Collaborate cross-functionally with QA, QC, Validation, and Manufacturing teams.
• Provide technical support during audits and regulatory inspections (e.g., FDA, EMA).
• Contribute to lifecycle management of processes including scale-up, tech transfer, process changes, raw material assessments and supplier qualification.
• Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory and Quality teams.
• Be accountable for the success of company and department projects/activities and ensure on-time deliverables to meet program commitments. Prepare periodic reports and present data to internal and external stakeholders as needed.
• Knowledge management by preparing templates, procedures, and effective training to ensure process are effectively transferred to the operations team.
• Work with operations team to create a culture of accountability, ownership, and continuous improvement.
• Respect all safety, laboratory policies, and practices on site.
• Work across departments and/or sites.
• Work with process engineers and manager to align the priorities of the team with those of the department.
• Able to work independently; shows initiative and able to work with all levels of staff.

Requirements:

• Bachelor’s degree in these same disciplines and a minimum of 5 years of relevant and progressively responsible experience in these same areas. Or Master’s in science/chemical engineering or related field and a minimum of 3 years of progressively responsible experience in biologics/gene therapy manufacturing, MS&T or AS&T roles. At least 5 years of related experience in a GMP biologics manufacturing environment
• Previous GMP experience in handling deviation, change controls, CAPA using appropriate quality system is required.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Ability to work cross functionally within the organization as part of a project team.
• Prior cell therapy experience is highly preferred.
• Involvement in prior manufacturing process tech transfer is preferred.
• Work experience in biologics for late-stage and commercialization of products with a good understanding of GMP operation is required.
• Work in a cross-functional matrix environment and collaborate with internal and external functions including Regulatory, and Quality teams.
• Demonstrated proficiency with regulatory requirements, USP, and ICH guidelines.
• Experience in using the statistical analysis tools (e.g. JMP) and/or sufficient knowledge of statistical concepts required to evaluate trends.

Skills:

• Excellent communication skills with good technical writing skills with a proven ability to work with internal and external partners
• Project management skills including planning, execution, risk and change management
• Good interpersonal and communication skills
• Effective team player
• Analytical skills with logical thinking problem solving skills
• Good knowledge of Microsoft office

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 25 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.

This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, 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 blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $120,988 - $142,405/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate 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, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional 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.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.