Manufacturing Engineer

Yoh, A Day & Zimmermann Company; Rosenberg (TX); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health Insurance

401K Retirement Savings Plan

Employee Assistance Program (EAP)

Certification and training programs

Direct Deposit & weekly epayroll

Job summary

Yoh, a Day & Zimmermann company, is seeking an experienced Manufacturing Engineer to join a pharmaceutical manufacturing organization in Rosenberg, TX. The role involves hands-on floor engineering, supporting day-to-day operations and collaborating with Manufacturing, Quality, Maintenance, Packaging, Validation, and R&D to ensure FDA and cGMP compliance.

The ideal candidate has pharma manufacturing engineering experience on liquid and/or semi-solid products, with strong troubleshooting,

Qualifications

• Bachelor’s degree in Mechanical, Chemical, Industrial, Manufacturing, Electrical Engineering or related field.
• 3–5+ years of pharmaceutical manufacturing engineering experience (5+ preferred).
• Strong knowledge of FDA requirements, cGMP, and regulated pharmaceutical manufacturing.
• Direct experience with semi-solid and/or liquid pharmaceutical products.
• Hands-on troubleshooting of manufacturing and packaging equipment.
• Experience with equipment installation, commissioning, startup, qualification, and validation.
• Familiar with IQ/OQ/PQ, process validation, and cleaning validation.
• Experience with deviations, RCA, CAPA, and change control.
• Willingness to spend significant time on the manufacturing floor.
• Strong analytical, troubleshooting, communication, and problem-solving skills.

Responsibilities

• Provide hands-on engineering support to pharmaceutical manufacturing operations.
• Troubleshoot manufacturing and packaging equipment issues to minimize downtime and improve reliability.
• Support equipment installation, commissioning, startup, qualification, and validation activities.
• Develop and execute engineering and validation documentation, including IQ/OQ/PQ.
• Support process validation and cleaning validation activities.
• Investigate manufacturing deviations and perform Root Cause Analysis (RCA).
• Develop and implement CAPA and change controls.
• Identify and implement opportunities to improve throughput, productivity, labor efficiency, and OEE.
• Support manufacturing process improvements and cost-reduction initiatives.
• Collaborate cross-functionally with Manufacturing, Quality, Maintenance, Packaging, Validation, and R&D teams.
• Develop and revise SOPs, manufacturing procedures, and work instructions.
• Support regulatory, customer, and internal audits.
• Ensure engineering and manufacturing activities comply with applicable FDA, cGMP, safety, and quality requirements.

Skills

Pharmaceutical engineering

Floor-time experience

Troubleshooting

IQ/OQ/PQ

CAPA & change control

Lean/Six Sigma

SAP

FDA cGMP knowledge

Analytical skills

Communication skills

Education

Bachelor’s degree in Mechanical, Chemical, Industrial, Manufacturing, Electrical Engineering

Tools

SAP ERP

Job description

Yoh Life Sciences is seeking an experienced Manufacturing Engineer to join a pharmaceutical manufacturing organization in Rosenberg, TX. This is a hands-on, floor-oriented engineering position supporting day-to-day pharmaceutical manufacturing operations.

The Manufacturing Engineer will work closely with Manufacturing, Quality, Maintenance, Packaging, Validation, and R&D to troubleshoot equipment and process issues, improve manufacturing performance, support new product and equipment initiatives, and ensure compliance with FDA and cGMP requirements.

The ideal candidate will have direct pharmaceutical manufacturing engineering experience, particularly with liquid and/or semi-solid products, and be comfortable spending significant time on the manufacturing floor.

#IND-SPG

Estimated Min Rate: $80000.00

Estimated Max Rate: $100000.00

Title:

Manufacturing Engineer

Location:

Rosenberg, TX

Employment Type:

Direct Hire

Schedule:

Monday–Friday, 8:00 AM–5:00 PM

Salary:

$80,000 - 100,000 annually

Key Responsibilities:

• Provide hands-on engineering support to pharmaceutical manufacturing operations.
• Troubleshoot manufacturing and packaging equipment issues to minimize downtime and improve equipment reliability.
• Support equipment installation, commissioning, startup, qualification, and validation activities.
• Develop and execute engineering and validation documentation, including IQ/OQ/PQ.
• Support process validation and cleaning validation activities.
• Investigate manufacturing deviations and perform Root Cause Analysis (RCA).
• Develop and implement CAPA and change controls.
• Identify and implement opportunities to improve throughput, productivity, labor efficiency, equipment reliability, and Overall Equipment Effectiveness (OEE).
• Support manufacturing process improvements and cost-reduction initiatives.
• Collaborate cross-functionally with Manufacturing, Quality, Maintenance, Packaging, Validation, and R&D teams.
• Develop and revise SOPs, manufacturing procedures, and work instructions.
• Support regulatory, customer, and internal audits.
• Ensure engineering and manufacturing activities comply with applicable FDA, cGMP, safety, and quality requirements.

Required Qualifications:

• Bachelor’s degree in Mechanical, Chemical, Industrial, Manufacturing, Electrical Engineering, or a related engineering discipline.
• 3–5+ years of pharmaceutical manufacturing engineering experience, with preference for candidates with 5+ years.
• Strong knowledge of FDA requirements, cGMP, and regulated pharmaceutical manufacturing practices.
• Direct experience manufacturing semi-solid products, such as creams, ointments, and suppositories, and/or liquid products, including solutions and suspensions.
• Hands-on experience troubleshooting manufacturing and packaging equipment.
• Experience with equipment installation, commissioning, startup, qualification, and validation.
• Working knowledge of IQ/OQ/PQ, process validation, and cleaning validation.
• Experience with deviations, Root Cause Analysis (RCA), CAPA, and change control.
• Ability and willingness to spend significant time on the manufacturing floor supporting daily operations.
• Strong analytical, troubleshooting, communication, and problem-solving skills.

Preferred Qualifications:

• Experience with New Product Introduction (NPI), process scale-up, and technology transfer.
• Experience developing User Requirement Specifications (URS).
• Experience with Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Proven success improving throughput, productivity, labor efficiency, equipment reliability, and OEE.
• Demonstrated ability to reduce downtime and optimize manufacturing costs.
• Experience with Lean Manufacturing, Kaizen, Six Sigma, and 5S methodologies.
• Experience developing and revising SOPs and manufacturing work instructions.
• Experience supporting regulatory, customer, and internal audits.
• Experience using SAP or a comparable ERP system.

What’s In It for You?

Benefits include:

• 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)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

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.

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.

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.