This role pays less than
79%
of similar roles. Most pay
$197,125–$275,625
— the shaded band above.
At the midpoint, this role pays about
$183k
versus about
$236k
for comparable roles.
Based on 240 similar postings.
Employer
About MSD
MSD (Merck Sharp & Dohme) is the international name for Merck & Co., a major U.S.-based pharmaceutical company.
MSD currently has
15 open roles
on FindRole.
Listed pay typically runs
$117,000–$184,200
across 15 roles with salary data.
Associate Director, Engineering will lead the site validation organization at a manufacturing facility specializing in antibody-drug conjugates (ADCs). This role involves building and leading the validation team, establishing governance standards, and managing the Validation Master Plan from design through operation. Key responsibilities include overseeing equipment and system validation for drug substance and drug product, managing continued process verification, cleaning validation, and computer system validation strategies. The candidate will engage with engineering firms during detailed design, oversee engineering batches, and serve as a subject matter expert during health authority inspections. Required expertise includes experience in cGMP biologics, sterile manufacturing, and high-potency compounds. Technical skills include knowledge of chromatography skids, isolators, filtration systems, and risk-based tools like FMEA or Six Sigma to ensure regulatory compliance and successful technical transfers for complex oncology treatments.
What does a Engineering Director earn?
Median $307000 from 31 postings across 22 companies.
Build and lead the site validation organization including governance, standards, and succession plans.
Manage all aspects of equipment and system validation for drug substance and drug product manufacturing.
Drive continuous improvements with the global validation Center of Excellence to ensure regulatory compliance.
Lead engineering design firms during the detailed design phase for manufacturing systems.
Own the Validation Master Plan, including cleaning, computer system, and lifecycle management strategies.
Oversee equipment qualification, factory acceptance testing (FAT), and site acceptance testing (SAT).
Author and review technical documents such as manufacturing batch records, SOPs, and technical memos.
Serve as the subject matter expert during health authority inspections and regulatory submissions.
What we're looking for
Bachelor’s degree in engineering, science, or a related discipline.
10+ years of increasing responsibility in validation, engineering, or technical operations within a cGMP biologics, sterile manufacturing, or pharmaceutical environment.
Experience with high-potency compounds, containment systems, isolator technologies, and antibody-drug conjugate manufacturing is strongly preferred.
Experience in large-scale commercial drug substance and/or drug product facility start-ups is highly desirable.
Proficiency in equipment qualification (IQ/OQ), building systems validation, and production system validation.
Expertise in aseptic process simulation, cleaning validation, and computer system validation (CSV).
Ability to lead technical teams through FAT, SAT, engineering batches, and PPQ runs.
Experience with risk-based manufacturing tools like FMEA and data-driven root cause analysis such as Six Sigma.
Remote (West Point, PA)8 days ago
$142,400–$224,100
Robotics
Machine Vision
Artificial Intelligence
Deep Learning
Machine Learning
Automation Systems
Manufacturing Engineering
Commissioning
Qualification
Validation
Capital Project Management
Lean Manufacturing
Root Cause Analysis
Data Analysis
Technical Transfer
Remote (Wilmington, DE)17 days ago
$173,200–$272,600
cGMP
Process Engineering
Technology Transfer
Validation
Kaizen
Lean Six Sigma
HAZOP
Root Cause Analysis
CAPA
Change Management
New Product Introduction
Antibody Drug Conjugates
Remote (West Point, PA)9 days ago
$173,200–$272,600
Bioprocess Engineering
Upstream Cell Culture
Process Development
Technology Transfer
cGMP
Process Characterization
Scale-up
Validation
Antibody Therapeutics
Viral Clearance
Process Performance Qualification (PPQ)
Analytical Characterization
Product Development Lifecycle
Clinical Manufacturing
Remote (West Point, PA)8 days ago
$117,000–$184,200
Biologics
Cell Culture
cGMP
Process Development
Upstream Processing
Design of Experiments (DOE)
Technology Transfer
Mammalian Cell Culture
Chromatographic Techniques
Quality by Design (QbD)
Lean Six Sigma
Regulatory Submissions
IND
MAA
BLA
Statistical Data Analysis
GMP
Process Validation
Equipment Qualification
Root Cause Analysis
Lean Six Sigma
Project Management
Pharmaceutical Packaging
Medical Device Assembly
Technology Transfer
Process Design
Scale-up
Regulatory Compliance