





Job Description
Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to:
Reporting to the Associate Director of PTO Engineering, the Specialist, Technical Operations engineer is responsible for providing technical support of our Manufacturing Division-Wilson packaging and medical device assembly lines. Responsible for specifying, purchasing, installing, and qualifying new packaging and device assembly equipment. Also responsible for packaging and device assembly equipment performance, support, and troubleshooting for products packaged at our Manufacturing Division-Wilson. Works closely with Wilson and above-site departments for the transfer of new products and processes from our Research & Development Division or other our Manufacturing Division site to our Manufacturing Division-Wilson.
Primary Activities:
Primary activities include, but are not limited to:
Responsible for managing capital and expense projects for installation and qualification of new packaging and medical device assembly equipment and modifications/optimizations to existing equipment.
Provides technical assistance to packaging operations in the resolution of packaging and device assembly equipment problems for in-line products. This involves leading root cause analysis investigations for equipment-related quality events.
Provide technical support for the design, machinability evaluation, process performance qualification and qualification of new or modified packaging components and Medical Device and Combination products.
Technical support for the scale-up and technology transfer of pilot processes to production scale for our Manufacturing Division-Wilson. This includes support for equipment design, equipment qualification, process demonstration, process performance qualification, and process validation.
Responsible for authoring process change controls and completing tasks to implement packaging and device assembly equipment/process changes.
Provides technical assistance for quality and regulatory activities including site inspections and preparation of technical documents for FDA observation.
The basic function of this position is to, independently or as part of a project team, plan, design and implement technical projects related to packaging and medical device equipment/processes. Work requires a strong technical background and project management skills, as well as working knowledge of our company's methods, standards, procedure, and practices. Experience in equipment installation and qualification for complex systems. This position requires the engineer to be the technical subject matter expert for the assigned packaging lines and make recommendations for decisions associated with these lines and their associated products. Utilizes strong communication skills to lead project sub teams or be a key contributor on site and above-site sub teams. Leads implementation of new technology and new applications of existing technology.
Minimum education required:
BS in Engineering or equivalent and minimum of 1 year of experience with packaging/process equipment.
Required Experience and skills:
Mechanical aptitude to troubleshoot/resolve equipment issues.
Strong oral and written communication skills
Demonstrated teamwork skills.
Preferred experience and skills:
Experience in pharmaceutical industry.
Experience in Medical Devices and Combination products.
Project management skills
Experience in equipment qualification activities.
Experience in the use of Lean Six Sigma tools.
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:
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
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Adaptability, Adaptability, Data Analysis, Electronic Troubleshooting, Engineering Standards, Equipment Troubleshooting, Fault Repair, Leadership Training and Development, Manufacturing Quality Control, Manufacturing Scale-Up, Medical Device Management, Medical Devices, Packaging Engineering, Packaging Equipment, Packaging Lines, Packaging Processes, Packaging Testing, Process Design, Process Verification, Project Management, Project Support, Root Cause Analysis (RCA), Sealing Machines, Teamwork, Technical Projects {+ 1 more}Preferred Skills:
Job Posting End Date:
06/14/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R350650