Job Description

Our Biologics Technical Operations Unit is seeking a highly motivated individual to fill an open Sr. Specialist Bio ExM Tech Ops position to support drug substance manufacture within our External Manufacturing Network.

This is an exciting opportunity to work with key strategic external
partners, grow technical experience in biologics or vaccines manufacturing, and work on high visibility network initiatives
Our team strives to provide technical excellence in our work and be
strong partners, collaborators, and leaders within the large molecule line of business at our company.

Our Engineers help ensure that 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.

Primary responsibilities for this position include, but are not limited to, the following:

• Work with external partners to achieve business goals and to establish a common culture that benefits both our company, external partners, and patients
• Lead and act as the primary interface on technical issues between technical operations and external partner drug substance manufacturers
• Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events
• Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
• Develops solutions to complex technical issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products.
• Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities
• Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with operations, quality, and external partners
• Ensure that external partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with operations, quality, and regulatory.
• Responsible for participation in creating, sharing, and adopting best practices and business process strategies

Education requirements:
• Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or
Chemistry/Biology, or other related science or engineering field

Required skills and Experience:
• A minimum of 4 - 7 years of relevant work experience in GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
• Ability to work independently as well as excellent organizational skills
• Strong professional and interpersonal communication skills
• Must be able to multi-task and work within tight deadlines

Confidential
• Strong analytical problem-solving skills, root cause analysis, and risk
assessment/mitigation
• Proven team building skills
• Excellent command of English (both written and oral)
• Travel will be a requirement of this position at approximately 25%

Preferred Experience and Skills:
• Experience in biologics manufacturing
• Statistics experience
• Experience in deviation management and/or change control and/or equipment support, and/or project management.
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

THE COMPANY

Who we are …
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.

For more than a century, we have been inventing for life, bringing forward
medicines and vaccines for many of the world's most challenging diseases.
Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the
prevention and treatment of diseases that threaten people and animals around the world

What we look for …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us -and start making your impact today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Biological Manufacturing, Biopharmaceutics, Change Control Processes, Chemical Engineering, Customer-Oriented, Deviation Management, Disease Prevention, Engineering Standards, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, Interpersonal Communication, Maintenance Engineering, Manufacturing Process Validation, Pharmacology, Process Improvement Projects, Process Optimization, Project Management, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis (RCA), Strategic Thinking, Teamwork {+ 2 more}

Preferred Skills:

Job Posting End Date:

08/11/2025

*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.