Sr. Engineer - Process Development

Yoh Services LLC; Waltham (MA); On-site; USD 46,287 - 66,124; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision Benefits

Health Savings Account (HSA)

Life & Disability Insurance

MetLife Voluntary Benefits

Employee Assistance Program (EAP)

401(k) Retirement Savings Plan

Direct Deposit & weekly e-payroll

Referral Bonus Programs

Certification and training opportunities

Job summary

Yoh Services LLC in Waltham, Massachusetts, is seeking a Sr. Engineer in Process Development to lead the development of scalable, robust drug-substance processes for mRNA manufacturing. With a requirement of 6+ years of experience and a degree in Chemical or Biomedical Engineering, candidates will engage in digital tool implementation and cross-functional collaboration.

Benefits include medical, dental, vision, and a 401(k) retirement savings plan. Join a dedicated team committed to mRNA development.

Qualifications

• 6+ years (Master’s) or 8+ years (Bachelor’s) of relevant experience is required.

Responsibilities

• Lead development and execution of scalable drug-substance processes.
• Implement digital tools for process data acquisition.
• Contribute to the design of mRNA manufacturing processes.
• Author and coordinate documents for cross-functional teams.
• Collaborate with various teams for electronic batch records.
• Prepare technical reports supporting scale-up activities.

Skills

Experience in process development, tech transfer, and/or scale-up

Experience in biopharmaceutical manufacturing

Experience with mRNA drug substance

Experience implementing and maintaining electronic batch records (eBRs)

Experience using Tempo Apprentice

Education

Bachelor’s degree in Chemical Engineering, Biomedical Engineering, or related field

Master’s degree in relevant field

Job description

Sr. Engineer - Process Development

The Sr. Engineer reports to the Principal Engineer and is an integral part of the mRNA Drug Substance Process Development team.

Responsibilities

• Lead and assist in development and execution of scalable, robust drug‑substance processes, including scale‑up, pilot batches, and generation of scale‑down models for GMP manufacturing. (40%)
• Lead implementation of digital tools for process data acquisition, such as electronic lab notebooks and electronic batch records. (40%)
• Contribute to the design of mRNA manufacturing processes by reviewing and developing batch records, master production records (MBR), and standard operating procedures (SOPs). (10%)
• Author, review, and coordinate MBRs, SOPs, and other documents, communicating with cross‑functional manufacturing and analytical teams. (10%)
• Collaborate with R&D, process development, QA, project management, regulatory affairs, and legal teams to harmonize electronic batch records and implement eBRs & data capture strategy, generating SOPs, MBRs, protocols, and obtaining QA approvals. (5%)
• Prepare technical reports and presentations supporting scale‑up activities and process improvements; generate technical reports such as batch summaries, process descriptions, tech transfers; present batch performance and technical issues. (10%)

Education and Experience Requirements

• 6+ years (Master’s) or 8+ years (Bachelor’s) of relevant experience is required.
• Bachelor’s degree or Master’s degree in Chemical Engineering, Biomedical Engineering, or related field.

Key Skills, Abilities, and Competencies

• Experience in process development, tech transfer, and/or scale‑up to support manufacturing of biopharmaceuticals.
• Experience in biopharmaceutical manufacturing, MSAT, or process development (minimum 4 years).
• Experience with mRNA drug substance (strongly preferred).
• Experience implementing and maintaining electronic batch records (eBRs) (minimum 1 year); experience using Tempo Apprentice preferred.

Benefits

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401(k) Retirement Savings Plan
• Direct Deposit & weekly e‑payroll
• Referral Bonus Programs
• Certification and training opportunities

Estimated Min Rate: $33.60

Estimated Max Rate: $48.00

Equal Opportunity Employer

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Legal and Compliance Statements

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice