Job Description
The Specialist, Engineering will serve as a member of the Technical Operations team supporting thaw, pool, and filling manufacturing areas. The Specialist, Engineering is expected to collect and interpret information, to develop solutions and to make decisions with high liability to projects of varying scopes. Very minimal supervision, guidance, and direction are employed by the Associate Director, however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort.
Primary responsibilities:
This role will collaborate with Operations, Quality, and other support groups to meet targeted manufacturing and compliance initiatives within an Integrated Product Team, and to execute and support key projects for the business including continuous improvement changes and strategic production initiatives. The subject position will be responsible for the following:
- Provides technical assistance to manufacturing operations in the resolution of thawing/pooling/filling equipment problems for in-line products. This involves leading root cause analysis investigations for equipment-related quality events.
- Provides written scientific justification for proposed changes by conducting literature search, designing and executing experiments, analytically reviewing current and past data, and demonstrating the impact of process changes on product quality, production efficiency, or productivity.
- Provides technical assistance for quality and regulatory activities including site inspections, preparation of technical documents for NDA supplements, FDA observation, and environmental process issues.
- Responsible for the accuracy of Process Descriptions and Critical Process Parameter Memos. This requires a thorough knowledge of the Drug Product operations, the hazards involved, and the in-process controls necessary to obtain reproducible results.
- Responsible for completing all process engineering/process development activities with the highest regard for all of our Company Divisional policies and Durham site procedure for safety, quality, and regulatory compliance.
- Review literature pertaining to pharmaceutical aseptic filling and lyophilization in order to introduce new profitable/productivity ideas into the Drug Product operation.
- Provide technical support for the design, machinability evaluation, process performance qualification and qualification of new or modified equipment components
- Supports 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.
Education Minimum Requirement:
- Bachelor of Science Degree (BS) in Engineering or related fields with two (2) years’ experience in pharmaceutical operations, technical services, or quality operations;
Required Experience and Skills:
- Minimum of 2 years relevant industrial experience.
- Experience working in a GMP Pharmaceutical Environment.
- Demonstrated leadership and teamwork skills.
- Proven communication skills. Strong oral and written communication skills.
- Mechanical aptitude to troubleshoot/resolve equipment issues.
Preferred Experience and Skills:
- Experience in deviation management and/or change control and/or equipment support and/or project support role.
- Experience in pharmaceutical industry.
- Project management skills.
- Experience in writing process change controls.
- Experience in the use of Lean Six Sigma tools. #EBRG´s #VetJobs
Required Skills:
Adaptability, Adaptability, Change Control Management, Change Controls, Collaborative Leadership, Competency Management, Data Analysis, Equipment Designing, Equipment Troubleshooting, Evaluate Information, Good Manufacturing Practices (GMP), Leadership Theories, Lean Manufacturing, Operations Engineering, Organizational Leadership, Personal Initiative, Procedure Writing, Process Definition, Process Optimization, Product Analysis, Professional Integrity, Project Implementations, Project Leadership, Project Management, Project Scoping {+ 9 more}
Preferred Skills:
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The primary location for this posting is:
USA - North Carolina - Durham (Old Oxford)
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$87,300.00 - $137,400.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
Additional location(s) Compensation Information:
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:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
NA
Job Posting End Date:
10/21/2026
*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.
