Associate. Specialist, Engineering

HireLifeScience; Wilson (NC); On-site; USD 72,000 - 113,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Paid Holidays

Vacation

Sick Days

Job summary

HireLifeScience seeks an Associate Specialist, Technical Operations Engineer to provide hands-on support for packaging and medical device assembly lines at our Wilson site. You will troubleshoot equipment, review data, and prepare documentation while coordinating with Operations, Quality, and Maintenance.

The role emphasizes equipment qualification, change control, deviation investigations, and technology transfer support, with potential involvement in new capital projects and supplier

Qualifications

• BS in Engineering or equivalent technical degree.
• Mechanical aptitude and troubleshooting packaging/process equipment.
• Able to collect, organize, analyze, and communicate technical information.
• Strong oral and written communication; teamwork oriented.
• Ability to manage multiple priorities and support project workflows.

Responsibilities

• Provide technical assistance for packaging and device assembly equipment problems.
• Author quality incidents; support root cause analysis and deviations.
• Assist with design, qualification, and qualification of packaging components.
• Support scale-up, tech transfer, and equipment readiness for new products.
• Prepare and execute change controls; document packaging/equipment changes.
• Analyze equipment performance data and support line trials.
• Assist with site records, audits, and project administration.

Skills

Mechanical aptitude

Troubleshooting

Data analysis

Documentation

Cross-functional teamwork

Process understanding

Communication skills

Project coordination

Education

BS in Engineering or equivalent

Tools

Equipment qualification

Lean Six Sigma tools

Documentation management systems

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

• 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}

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.

The salary range for this role is $71,900.00 - $113,200.00.

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.

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.

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