Specialist, Manufacturing Engineer

Job Description

Pharmaceutical Operations and Clinical Supply is seeking a highly motivated individual for a Manufacturing Engineering position to support specialty dosage forms and oral solid dosage GMP development activities. 

This role is primarily responsible for continuous improvement of processing activities including the setup, operation, and cleaning of equipment for clinical batch processing and equipment troubleshooting within our clinical supply Formulation Laboratory and Experimentation (FLEx) Early Development Center (EDC).

The successful candidate will become an owner and trainer of key pieces of equipment, focusing on specialty setups (e.g. potent processing isolators, dry powder inhalers, autoencapsulation).  They will lead the team through room setup, equipment assembly and disassembly, along with managing and completing GMP documentation. They will also build a strong team dynamic through continual sharing of knowledge and identification of improvements. They will work closely with peer specialists, formulation scientists, facility engineers and automation engineers to fix equipment/system issues and solve root causes. By taking initiative and owning improvement projects to completion, the candidate will help the team progress on our continuous improvement journey.

Primary Activities

• Lead improvement activities on specialty equipment trains in the oral solid dosage facility

• Coordinate processing and troubleshooting on designated equipment trains

• Define and improve standard work, SOPs, BTD, and overall production flow

• Support standard Non-Sterile processing as time allows.

• Ensure adherence to Good Manufacturing Practices, draft and review process steps, SOPs, quality procedures, safety, and environmental standards.

• Perform documentation activities on room and equipment logs and batch sheets in compliance with Good Documentation Practices.

• Develop experience to become an equipment expert and share knowledge by teaching others.

• Troubleshoot equipment problems.

• Execution of GMP batch documentation in accordance with local and global operating procedures.

• Provide support to engineering and formulations staff on Good Manufacturing Practices, equipment operations, facility maintenance and batch specific items.

• Identify and document deviations and atypical events.

• Lead investigations and document as required.

• Support investigations and the implementation of corrective/preventive actions.

• Support external and internal audits, tours and inspections. 

• Author or assist with the development of SOPs.

• Complete training and ensure it is up to date.

• Interface with engineering and maintenance personnel for equipment repair issues, ensuring proper procedure and change control is followed. Ensure downtime minimization.

• Lead improvement initiatives.

Qualifications

Required Qualifications

• Bachelor’s in Engineering or Pharmaceutical Sciences and two years of experience in a related field

• Independent planning, scheduling, and time management skills. 

• Ability to troubleshoot and resolve issues utilizing digital skill sets

• Demonstrated mechanical aptitude

Preferred

• Experience in GMP pharmaceutical plant operations

• Experience with GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)

• Working knowledge of regulatory requirements within GMP manufacturing facilities, and demonstrated focus on details and proper execution of batch manufacturing.

• Experience with some of the following: Oral Solid Dosage, Tablet Compression, Encapsulation, Spray Drying, Film Coating, Dry Powder Inhalers, Drug Product Device assembly lines, Isolators, Containment technology

• Experience working with Lean / Six Sigma and continuous improvement projects

• Experience with: PI Visions, Equipment HMI use, SAP, Microsoft Office (Word, Excel and Outlook). 

• Experience working with safety team on industrial hygiene monitoring, investigations, improvements, and focus on safety working culture.

#eligibleforERP

FLEx2026

#PSCS

Required Skills:

Biopharmaceutical Operations, Change Management, Data Analysis, Equipment Qualification, GMP Guidelines, GMP Validation, Maintenance Supervision, Manufacturing Process Improvements, Process Qualification, Risk Management, Sterile Processing, Teamwork, Technical Calculations, Technical Support, Technology Transfer

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$79,200.00 - $124,700.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/25/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.