Sr. Specialist, Engineering (m/f/d)

MSD; Roma; Hybrid; EUR 45.000 - 77.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. is seeking an experienced engineer to support sterile drug product manufacturing within our External Manufacturing Network in Europe. The role focuses on technical leadership, transfer of new sterile products, and collaboration with external partners to implement state‑of‑the‑art processes.

The candidate will lead investigations, CAPAs, change controls, and risk assessments, while working with multiple internal teams and external sites. Travel is expected (~25%).

Qualifikationen

• Bachelor’s degree in engineering, biology, chemistry, or related field.
• Minimum 7 years in manufacturing, start-up, or tech transfer.
• At least 3 years in sterile/aseptic Drug Product processing.
• Experience in Relationship Management.

Aufgaben

• Manage technical issues of global external manufacturing of drug product.
• Provide technical leadership for sterile drug product management.
• Support tech transfers to contract manufacturing sites.
• Lead cross-functional teams on CAPA and change controls.
• Coordinate with third-party manufacturers and regulatory interactions.
• Support Health Authority inspections and risk mitigation.

Kenntnisse

Change Control

CAPA

GMP

Regulatory Compliance

Technical Transfer

Risk Assessment

Project Management

Cross-functional Collaboration

English Proficiency

Ausbildung

Bachelor's degree in engineering/related

Jobbeschreibung

Job Description

Our Large Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open position to support sterile drug product manufacture within our External Manufacturing Network in Europe. This is an exciting opportunity to work with key strategic external partners, grow technical experience in sterile manufacturing, and work on high visibility network initiatives with direct access to senior management. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the large molecule lines of business at our company.

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.

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

• Manages technical issues relating to the global external manufacturing of commercial Drug Product.

• Provide technical leadership within Technical Operations group for the management of sterile drug product.

• Support technical transfers of new sterile drug product to our contract manufacturing sites.

• Driving change both internal and external ensuring state of the art technology and processes are implemented and maintained.

• Lead to resolve technical issues relating to a product line or major technical projects within Technical Operation.

• Provide direct leadership for day-to-day technical activities for commercial drug product manufacturing –i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.

• Lead and act as the primary interface on technical issues between Technical Operations and third-party drug product manufacturers.

• Provide technical leadership on Change Controls, investigations, and CAPAs and support of Health Authority Inspections.

• Support / Lead critical technical projects relating to the manufacturing of commercial sterile drug product.

• Organize and lead ad hoc cross functional teams to manage investigations and implementation of CAPA and change controls.

• Coordinates and manages risk assessments and develops solutions to complex 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.

• This role includes approximately 25% travel.

Qualifications

Education and Minimum Requirements:

• Bachelor’s degree in engineering, biological/chemistry sciences or related discipline

• A minimum of 7 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer.

• A minimum of 3 or more years of experience in sterile/ aseptic Drug Product processing including formulation and filling.

• Experience in Relationship Management

Required Skills and Experience

• Ability to work effectively across boundaries to build strong collaborative relation with otherinternal teams, such as; Global Technical Operations, Sterile, External Services partner groups, Small and Large Molecule Sites and external partners.

• Strong professional and interpersonal communication skills are also required.

• Must be able to multi-task and work within tight deadlines.

• Flexibility and the ability to work independently as well as excellent organizational skills.

• Strong knowledge of Quality systems, Change Control Drug Product Manufacturing and Validation

• Strong analytical problem-solving skills, root cause analysis and risk assessment/mitigation

• Proven team building skills

• Excellent command of English (both written and oral).

Preferred Experience and Skills

• Experience managing direct reports (none assigned to the role at the moment)

• Lean Manufacturing / Six Sigma Experience

• Project management experience

• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

Additional location(s) Compensation Information

The base salary range for the additional location (Italy) of this position is: (EUR 45300 - 77000)

This range reflects the Company’s reasonable expectation of the base salary applicable to this role at the time of posting. This will be based on an individual’s experience, skills, effort, responsibilities, organization needs and compensation levels within their peer group. If applicable, employees may also be eligible for annual bonus and long-term incentives or other benefits. This role is part of a collective bargaining agreement / national collective labor agreement. Our Talent Acquisition team will provide further information to you, if applicable. The applicable NCBA is CCNL Chimico-Farmaceutico, Classification ‘Quadro’, Level A3.

Required Skills

Business Agility, Change Control Processes, Controls Management, Cross-Functional Project Management, Customer-Oriented, Deviation Management, Good Manufacturing Practices (GMP), Manufacturing Process Validation, Manufacturing Production, Multitasking, Process Innovation, Process Optimization, Regulatory Compliance, Relationship Management, Risk Avoidance, Root Cause Identification, Schedule Adherence, Strategic Thinking, Task Management, Technical Support, Technical Transfer

Preferred Skills

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

No relocation

VISA Sponsorship

No

Travel Requirements

25%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

10/31/2026

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.