Senior Specialist, Engineering- Biologics External Manufacturing Technical Operations

Merck & Co.; West Point (PA); Presencial; USD 117.000 - 184.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Descripción de la vacante

HireLifeScience seeks a Senior Specialist (Engineering) for Biologics External Manufacturing Technical Operations. The role focuses on tech transfer with external partners, maintaining GMP documentation, and supporting commercial manufacturing processes at external sites.

Ideal candidates have 8+ years in GMP environments, strong project management, and excellent communication skills to collaborate with operations, quality, and regulatory teams.

Formación

• Bachelor's degree required in chemical/biochemical engineering, pharmaceutical science, chemistry/biology or related field.
• Minimum of 8 years post-bachelor's GMP experience in Operations, Technical Operations, Technology or Engineering.
• Ability to work independently with strong organizational and communication skills.

Responsabilidades

• Lead and act as the primary interface on technical issues between operations and external partner drug substance manufacturers.
• Oversee technical transfer activities including GMP documentation (Master Batch Records, change control, protocols, reports, qualifications).
• Manage technical activities for commercial manufacturing at external partner including change control, process improvements, and risk assessment.

Conocimientos

Biologics

Deviation Management

DP Operations

Facility Design

GMP Compliance

Manufacturing

Process Validation

Project Management

Regulatory Compliance

Sterile Manufacturing

Technical Transfer

Independent Work

Technical Writing

Educación

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

Descripción del empleo

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.-

Responsibilities include:

• 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.

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:

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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 range:

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.

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 .

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.

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

Job Posting End Date:

10/17/2026

*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.