Technical Operations Specialist-2

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. -

At the Durham Vaccine Facility in Durham, North Carolina, the Global Vaccine Technology & Engineering (GVTE) Team is seeking candidates to fill IPT Engineering positions to partner with Manufacturing Operations, Quality Operations and Process Automation. GVTE provides technical engineering and manufacturing support for the production of our Company's live virus vaccines at Durham.

Position Description:

We currently have an exciting opportunity for an Engineer to join our vaccine manufacturing Technical Operations department within out Company's Manufacturing Division, supporting a sterile fill, finish, lyophilization vaccine manufacturing facility in Durham, NC. This state of the art facility, started in 2004, is manufacturing our Company's lifesaving vaccines. Due to the importance of this facility in our Company's Vaccine Manufacturing Supply Chain, the facility has seen rapid growth in production volumes and new employees over the last several years.

The IPT (Integrated Process Team) Support Specialist will be part of a cross functional team charged with the technical support of the manufacturing shop floor in a fill-finish vaccine facility. This role requires the ability to execute multiple projects and activities across the IPT. Strategic and effective communication and collaboration skills are essential. The successful candidate will also have robust problem solving skills and a hands-on approach to equipment validation and problem solving, with a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuously learning is a requirement.

Primary Responsibilities

• Supporting the Cap and Inspect equipment area by analyzing complex processing problems through critical analytical thinking and "on the floor" troubleshooting
• Development of sound scientific justification for planned material and process and equipment changes
• Working with the Operations, Automation, and Quality functions to determine the breadth and scope of investigations to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition
• Preparing and/or providing guidance and review for regulatory filings, process descriptions, investigations, and change requests. Acts as a participant in domestic and international regulatory agency inspections
• Supporting all quality and safety initiatives
• Provide technical support to manufacturing shop floor for in-process analytics, controls, and troubleshooting
• Keeping the supervisor current on the progress of projects, and making improvement recommendations on production procedures
• Support on shift support during critical manufacturing runs such as Aseptic Process Simulation, protocol execution, and developmental runs
• Responsible for authoring process change controls and completing tasks to implement Drug Product equipment/process changes.
• Serve as a technical writer for Quality Notifications
• Provide technical support for the design, machinability evaluation, process performance qualification and qualification of new or modified equipment components

Position Qualifications:

Education Minimum Requirements

• Bachelor's degree in an Engineering or Science Related field

Required Experience and Skills

• Minimum two (2) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations or military
• Strategic and effective communication, leadership and teamwork skills

Preferred Experience and Skills

• Optimizing and troubleshooting aseptic processing operations such as formulation, filling, lyophilization, or automated inspection processes
• Familiarity with process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies

Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.-

Required Skills:
Accountability, Accountability, Adaptability, Change Control Management, Collaborative Communications, Corrective Action Management, Data Analysis, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices (GMP), Hardware Implementation, Healthcare Innovation, Leadership, Lean Manufacturing, Multi-Management, Personal Initiative, Process Automations, Process Optimization, Process Simulation, Professional Integrity, Project Management, Quality Assurance (QA) Standards, Quality Assurance Processes, Quality Operations, Risk Assessments {+ 5 more}

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

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".

The salary range for this role is
$85,600.00 - $134,800.00

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 .

You can apply for this role through (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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
12/25/2025
*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.

Requisition ID: R375115