Senior Specialist, Engineering- Biologics External Manufacturing Technical Operations

MSD Malaysia; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Specialist (Engineering) for Biologics External Manufacturing Technical Operations to support drug substance tech transfer and commercial manufacturing with external partners in our network.

The role emphasizes leadership of technical transfer activities, GMP documentation review, and driving process improvements while ensuring regulatory readiness and compliant operations for sterile biologics manufacturing.

Qualifications

• Minimum of 8 years post-bachelor's degree experience in a GMP functional area.
• Ability to work independently with strong organizational skills.
• Strong communication, problem-solving, and risk assessment abilities.

Responsibilities

• Lead and act as primary interface on technical issues between operations and external drug substance manufacturers.
• Manage technical transfer activities and GMP documentation (MBRs, change controls, protocols, reports).
• Drive process improvements, statistics, and investigations related to commercial manufacturing.
• Ensure readiness for regulatory inspections and adherence to GMP requirements across external partners.
• Collaborate with quality, regulatory, and partner teams to standardize work and best practices.

Skills

GMP Compliance

Technical Transfer

Project Management

Analytical Skills

Communication

Team Leadership

Education

Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology

Job description

Job Description Senior Specialist (Engineering), Biologics External Manufacturing Technical Operations

Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support drug substance tech transfer and commercial 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.

Responsibilities

• 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 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.
• 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.
• 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

Minimum Requirement: Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.

Required Experience and Skills

• Minimum of 8 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology or Engineering.
• 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.
• Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation.
• Proven team building skills.
• Travel will be a requirement of this position at approximately 25%.

Preferred Experience and Skills

• Experience in biologics or large molecule manufacturing.
• Project management 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.

Required Skills

• Biologics, Deviation Management, DP Operations, Facility Design, GMP Compliance, Manufacturing, Manufacturing Operations, Manufacturing Process Validation, Project Management, Regulatory Compliance, Sterile Manufacturing, Technical Transfer, Working Independently, Writing Technical Documents

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.

Equal Employment Opportunity

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.

Salary

The salary range for this role is $117,000.00 - $184,200.00 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.

Benefits

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.

Search Firm Representative Notice

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.

Job Facts

Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a

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

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.