Senior Validation Engineer

Merck Gruppe - MSD Sharp & Dohme; Dundalk (MD); Hybrid; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Validation Engineer to ensure compliance with cGMP regulations while executing critical qualification activities for facilities and equipment. This role demands a technical expert who will lead validation processes, manage complex projects, and collaborate with cross-functional teams to troubleshoot and resolve issues. If you are passionate about enhancing healthcare solutions and thrive in a dynamic environment, this opportunity is perfect for you. Join a company that values innovation and flexibility in the workplace, and help make a difference in patients' lives.

Benefits

Flexible Work Arrangements

Health Insurance

Retirement Plan

Professional Development Opportunities

Employee Assistance Program

Qualifications

• 5+ years of experience in a cGMP environment focusing on validation.
• Experience with facility startup projects and equipment qualification.
• Strong problem-solving skills and ability to lead teams.

Responsibilities

• Execute validation activities throughout design and qualification phases.
• Manage complex projects and troubleshoot process systems.
• Ensure compliance with cGMP standards and company procedures.

Skills

Validation Engineering

Project Management

Problem Solving

Communication Skills

Regulatory Compliance

Education

Postgraduate Degree in Engineering or Science

Tools

GMP Standards

Cleanroom Equipment

HVAC Systems

Bioreactors

Chromatography Systems

Job description

Job Description

We are seeking a Senior Validation Engineer who will play a crucial role in planning and executing qualification activities for our facilities, utilities, equipment, instruments, and processes, ensuring compliance with current Good Manufacturing Practice (cGMP) regulations and company policies. In this role, you will be a technical expert, supporting validation engineers and other departments in areas such as change controls, investigations, and corrective actions.

Bring energy, knowledge, innovation to carry out the following:

• Execute validation activities throughout facility design, build, and qualification phases, ensuring ongoing compliance.
• Perform qualification activities using a life cycle approach (Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, and Process Validation) in line with cGMP and company procedures.
• Apply regulatory requirements to the qualification of computerized systems, including documentation of protocols and reports.
• Maintain and update validation procedures to meet regulatory standards.
• Author, review, and approve testing protocols and reports.
• Manage complex projects, troubleshooting process systems, and collaborating with vendors.
• Participate in all phases of projects, from conceptual design through to commissioning and qualification.
• Initiate and complete investigations, corrective actions, and change controls for process systems.
• Ensure new process systems are integrated into maintenance and qualification programs.
• Oversee project management of system upgrades and modifications.
• Perform all duties according to cGMP standards and company procedures.
• Be flexible to take on additional tasks and responsibilities as required.

What skills you will need:

In order to excel in this role, you will more than likely have:

• A postgraduate degree in engineering or a science discipline is a plus.
• Approximately 5 years of experience in a pharmaceutical or similar cGMP environment, focusing on validation or engineering.
• Experience with facility startup projects and the commissioning and qualification of various equipment (e.g., cleanroom, HVAC, utilities, bioreactors, chromatography systems, process, cleaning, shipping).
• Proven skills in troubleshooting and providing technical solutions for GMP operations.
• Experience in managing vendor equipment and coordinating system design.
• Strong problem-solving skills with the ability to analyze and creatively address complex issues.
• Excellent communication and interpersonal skills for effective collaboration.
• Ability to translate strategic plans into actionable operational goals.
• Knowledge of pharmaceutical industry cGMP regulations and qualification/validation processes.
• Collaborative, inclusive, and proactive approach to teamwork.
• Strong project management skills and the ability to lead cross-functional teams.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply 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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/17/2025

*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.

Requisition ID:R339974