Associate. Specialist, Engineering

Caraway Therapeutics, Inc.; Wilson (NC); On-site; USD 72,000 - 113,000; Full time

Job summary

Caraway Therapeutics, Inc. is seeking an Associate Specialist for Technical Operations Engineering to provide hands‑on support for packaging and medical device assembly lines at the Wilson site.

You will troubleshoot equipment, review data, prepare documents, and coordinate with Operations, Quality, and Maintenance to ensure smooth operations. The role builds expertise in packaging processes, qualification, change control, deviation investigations, and capital projects, while supporting

Qualifications

• BS in Engineering or equivalent technical degree.
• Experience in packaging operations and device assembly is desirable.
• Strong oral and written communication skills.

Responsibilities

• Providing technical assistance to packaging operations in troubleshooting packaging and device assembly equipment problems.
• Authoring quality incidents and supporting root cause analysis and deviation investigations.
• Assisting with the design, qualification, and modification of packaging components and formats.
• Supporting scale‑up, technology transfer, and new product/process introductions.
• Preparing change controls and implementing packaging and device assembly changes.
• Building process understanding by analyzing equipment performance data and tracking issues.

Skills

Troubleshooting packaging equipment

Data analysis and reporting

Clear communication

Teamwork

Project documentation

Education

BS in Engineering or related technical field

Tools

Packaging equipment

Equipment qualification

Lean Six Sigma

Job description

Job Description

Position Overview

Reporting to the Associate Director of PTO Engineering, the Associate Specialist, Technical Operations Engineer provides technical support for the packaging and medical device assembly lines at the our Company Manufacturing Division Wilson site. This role supports equipment performance and project execution through hands‑on troubleshooting, data review, document preparation/execution, and coordination with Operations, Quality, Maintenance, and other site or above‑site partners. The Associate Specialist will develop technical capabilities in packaging processes, equipment qualification, change control, deviation investigation, capital execution, and system life cycle documentation while supporting the transfer of new products as well as the procurement, installation, and qualification of new equipment at the Wilson site.

Primary Activities

Primary activities include, but are not limited to:

• Providing technical assistance to packaging operations in the troubleshooting and of packaging and device assembly equipment problems for in‑line products.
• Authoring quality incidents and supporting root cause analysis and deviation investigations for process and equipment related quality events
• Assisting with the design, machinability evaluation, and qualification of new or modified packaging components, packaging formats, and Medical Device and Combination Products.
• Supporting scale‑up, technology transfer, and introduction of new products or processes by assisting with equipment readiness, process demonstration, and process performance qualification.
• Preparing, routing, and completing assigned tasks associated with process change controls and completing tasks to implement packaging and device assembly equipment/process changes.
• Building process understanding and robustness by supporting line trials, analyzing equipment performance data, tracking issues, and performing proactive process monitoring.
• Contributing to the site’s permanent inspection readiness by organizing and preparing technical documentation and providing support during regulatory audits.Performing site records management activities and assisting with document archival and retrieval.

Assisting with project administration activities including issuing purchase orders, reconciling invoices, and managing site work flows for the creation and closure of non‑production process orders.

The basic function of this position is to support shopfloor production, problem‑solving, and engineering project execution. Work requires technical acumen, attention to detail, organization skills, and working knowledge of our company’s methods, standards, procedure, and practices. This position is expected to build technical subject matter expertise for the assigned packaging lines while providing reliable hands‑on support, coordinating administrative and documentation tasks tied to technical work, and communicating effectively with cross‑functional partners.

Minimum Education Required

• BS in Engineering or equivalent technical degree.

Required Experience and skills

• Mechanical aptitude and interest in troubleshooting packaging and process equipment issues.
• Ability to collect, organize, analyze, and communicate technical information clearly
• Strong oral and written communication skills
• Demonstrated teamwork skills.
• Ability to manage multiple priorities, track actions, and support project documentation and workflows

Preferred experience and skills

• Experience in pharmaceutical industry, GMP manufacturing, or packaging operations.
• Experience in Medical Devices and Combination products.
• Experience with project, expense, and documentation management
• Experience in equipment qualification and working with vendors.
• Experience in the use of Lean Six Sigma tools, data trending, or process monitoring.

Required Skills

Applied Mathematics, Applied Mathematics, Cold Chain Management, Competency Management, Documentation Preparation, Document Management, Engineering Standards, Equipment Calibrations, Equipment Engineering, Equipment Implementation, Equipment Monitoring, Equipment Troubleshooting, Maintenance Supervision, Manufacturing Quality Control, Manufacturing Scale‑Up, Materials Science, Medical Device Manufacturing, Packaging Engineering, Packaging Equipment, Packaging Innovation, Packaging Operations, Packaging Processes, Packaging Science, Packaging Supplies, Packaging Testing {+ 10 more}

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.

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

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:

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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
$71,900.00 - $113,200.00

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 .

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):
NA

Job Posting End Date:
10/13/2026
*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.