Senior Validation Engineer

MSD; 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 leading qualification activities for facilities and equipment. This role involves executing validation processes, managing complex projects, and collaborating with various teams to enhance operational efficiency. The ideal candidate will possess strong problem-solving skills and a proactive approach to teamwork. Join a forward-thinking company committed to innovative solutions in healthcare, where your contributions will directly impact patient care and operational excellence.

Qualifications

• 5 years experience in cGMP environment focusing on validation.
• Strong project management and troubleshooting skills required.

Responsibilities

• Execute validation activities ensuring compliance with cGMP.
• Manage projects and collaborate with vendors on system designs.

Skills

Validation Engineering

cGMP Compliance

Project Management

Problem-Solving

Analytical Skills

Communication Skills

Education

Postgraduate Degree in Engineering or Science

Tools

Cleanroom Equipment

HVAC Systems

Bioreactors

Chromatography Systems

Job description

Join to apply for the Senior Validation Engineer role at MSD

4 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

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.

Responsibilities

1. Execute validation activities throughout facility design, build, and qualification phases, ensuring ongoing compliance.
2. Perform qualification activities using a lifecycle approach (DQ, IQ, OQ, PQ, and Process Validation) in line with cGMP and company procedures.
3. Apply regulatory requirements to the qualification of computerized systems, including documentation of protocols and reports.
4. Maintain and update validation procedures to meet regulatory standards.
5. Author, review, and approve testing protocols and reports.
6. Manage complex projects, troubleshoot process systems, and collaborate with vendors.
7. Participate in all project phases, from conceptual design to commissioning and qualification.
8. Initiate and complete investigations, corrective actions, and change controls for process systems.
9. Ensure new process systems are integrated into maintenance and qualification programs.
10. Oversee project management of system upgrades and modifications.
11. Perform duties according to cGMP standards and company procedures.
12. Be flexible to take on additional tasks as required.

Required Skills

1. A postgraduate degree in engineering or a science discipline is a plus.
2. Approximately 5 years of experience in a pharmaceutical or similar cGMP environment, focusing on validation or engineering.
3. Experience with facility startup projects and equipment qualification (e.g., cleanroom, HVAC, utilities, bioreactors, chromatography systems).
4. Proven troubleshooting and technical skills for GMP operations.
5. Experience managing vendor equipment and system design coordination.
6. Strong problem-solving and analytical skills.
7. Excellent communication and interpersonal skills.
8. Ability to translate strategic plans into operational goals.
9. Knowledge of cGMP regulations and validation processes.
10. Collaborative and proactive team approach.
11. Strong project management skills and leadership ability.

We keep the patient at the heart of everything we do, striving to find solutions for healthcare challenges.

As an equal opportunity employer, we value diversity and are committed to inclusive hiring. Please contact our Talent Acquisition Advisor if you need support during the recruitment process.

We offer flexible working arrangements through a hybrid model. Feel free to discuss what flexibility means to you during your application.

If you're ready to invent solutions for unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Additional Information

Merck & Co., Inc., Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted without a valid search agreement will be deemed property of our company. No fee will be paid for candidates hired through unapproved agency referrals.

Employee Status: Regular

Relocation: Not applicable

VISA Sponsorship: Not available

Travel Requirements: Not applicable

Flexible Work Arrangements: Not applicable

Shift: Not specified

Valid Driving License: Not specified

Hazardous Materials: Not specified

Job Posting End Date: 05/17/2025

Job Details

• Requisition ID: R339974
• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Production, Manufacturing, and Engineering
• Industries: Biotechnology, Pharmaceutical Manufacturing, Veterinary Services