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Associate Director Validation Jobs in Indiana (NOW HIRING)

Reproductive Freedom for All

$90K - $130K/yr

The North Carolina Associate Organizing Director will be responsible for developing and executing a ... Must be able to lead and attend in-person events; access to a vehicle/valid driver's license ...

Novartis

Site QC Head (Associate Director)

Indianapolis, IN · On-site

$138K - $257K/yr

Ensureappropriatemanagementof QC related validations, transfers, investigations related activities ... Direct experience with investigations and root cause analysis in pharmaceutical or medical device ...

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Associate Director Validation information

What is an associate director validation?

An Associate Director of Validation is a leadership role in the pharmaceutical, biotechnology, or medical device industries responsible for overseeing validation activities. This includes ensuring that equipment, processes, and systems meet regulatory standards and function as intended. The Associate Director manages validation teams, develops validation strategies, and ensures compliance with industry regulations such as FDA and GMP. They play a key role in quality assurance and help maintain the integrity of products and processes.

How does an associate director validation typically collaborate with cross-functional teams during major projects?

An Associate Director of Validation works closely with departments such as Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs to ensure that validation activities meet both internal standards and regulatory requirements. This often involves leading multi-disciplinary project teams, facilitating communication, and resolving challenges related to process or equipment validation. Regular meetings, joint risk assessments, and coordinated documentation are common, which helps streamline project timelines and maintain compliance. Effective collaboration is essential for successful product launches and ongoing process improvements.

What are the key skills and qualifications needed to thrive as an associate director validation, and why are they important?

To excel as an Associate Director Validation, you need in-depth knowledge of validation principles, regulatory guidelines (such as FDA, EMA), and a background in life sciences or engineering, often supported by advanced degrees. Familiarity with validation software, quality management systems (QMS), and industry-standard protocols like GAMP or ASTM E2500 is crucial. Strong leadership, project management, and cross-functional communication skills help drive teams and ensure compliance. These competencies are essential to maintain product quality, regulatory adherence, and efficient validation processes in a highly regulated environment.

What is the difference between Associate Director Validation vs Validation Manager?

AspectAssociate Director ValidationValidation Manager
CredentialsBachelor's or Master's in Life Sciences, Engineering, or related fields; often requires industry certificationsBachelor's or Master's in similar fields; certifications like ASQ or ISPE are common
Work EnvironmentLeads validation teams, oversees validation strategies, and collaborates with cross-functional departmentsManages validation projects, ensures compliance, and reports to senior management
Employer & Industry UsagePharmaceutical, biotech, and medical device industries; used in large organizationsSimilar industries; common in mid to large-sized companies for validation oversight

The Associate Director Validation typically holds a higher strategic role, overseeing validation teams and strategies, while the Validation Manager focuses on managing validation projects and ensuring compliance. Both roles require similar credentials and are vital in regulated industries, but the Associate Director has broader leadership responsibilities.

What are popular job titles related to Associate Director Validation jobs in Indiana?

For Associate Director Validation jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Associate Director Validation jobs in Indiana look for?

The top searched job categories for Associate Director Validation jobs in Indiana are:

What cities in Indiana are hiring for Associate Director Validation jobs?

Cities in Indiana with the most Associate Director Validation job openings:

Associate Director Validation jobs near you
Infographic showing various Associate Director Validation job openings in Indiana as of August 2026, with employment types broken down into 100% Full Time. Highlights an 73% In-person, and 27% Hybrid job distribution.

Associate Director of Engineering

Ossium Health

Indianapolis, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 6 days ago

Job description

About the Job

This is a high-impact leadership role at the center of our manufacturing and technical operations. As the Associate Director of Engineering, you will lead the engineering and maintenance function supporting GMP/GTP manufacturing, ensuring equipment, processes, and systems remain reliable, compliant, and scalable as we grow.

You will partner closely with Production, Manufacturing, Quality, Supply Chain, MSAT, and Facilities to position Engineering as both a technical problem solver and a strategic enabler of safe, high-quality, and reliable product supply. As a key member of the Site Operations Team, you will drive disciplined execution, risk-based decision-making, and continuous improvement across the site.

This role is ideal for a technical leader who thrives in complex, regulated environments, builds strong and accountable teams, and is energized by modernizing systems to support increasing production demand and new product launches. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications
  • Bachelor's degree in Engineering and 8+ years of experience in pharmaceutical or biotech manufacturing OR 12+ years of relevant engineering experience in a regulated manufacturing environment
  • 4+ years of people management experience leading engineers or technical staff
  • Strong working knowledge of CGMP/CGTP requirements and engineering support in regulated aseptic or sterile manufacturing environments
  • Experience with equipment qualification (IQ/OQ/PQ), validation, and change controls
  • Proven track record of improving equipment reliability and reducing unplanned downtime
  • Strong project management, documentation, and communication skills
  • Experience with root cause analysis, FMEA, and SOP development
  • This position is based full time onsite in our Indianapolis facility
Preferred Qualifications
  • Experience supporting commercial-scale pharmaceutical or biotech manufacturing, including tech transfers, in multiple functional areas
  • Familiarity with computerized maintenance management systems (CMMS)
  • Experience leading capital projects and facility expansions
  • Lean or Six Sigma certification
  • Experience implementing automation and digital engineering solutions
  • Experience interacting with regulatory inspectors (FDA, EMA, or equivalent)
  • Expertise in business intelligence and analytics (Tableau, Power BI, SQL)
Key Responsibilities
  • Lead, mentor, and develop a high-performing engineering team including facilities, validation, maintenance, and automation personnel
  • Be a key member of our Site Operations Team, ensuring reliable supply of product to patients
  • Own equipment lifecycle management including design input, commissioning, qualification, maintenance strategy, and retirement
  • Oversee capital projects from concept through execution, ensuring scope, budget, and timelines are achieved
  • Establish and improve preventive maintenance and reliability programs to reduce downtime and deviation risk
  • Partner with Manufacturing, QA, and MSAT to support process improvements and capacity expansion
  • Ensure engineering compliance with CGMP/CGTP, safety standards, and internal procedures
  • Lead root cause investigations related to equipment, utilities, and facility systems
  • Drive data-based reliability improvements using trend analysis and KPIs
  • Support inspection readiness and represent Engineering during regulatory audits
  • Develop long-term facility and infrastructure strategy aligned with commercial growth plans
  • Travel (domestic and international) when required (<10%) to support other sites

In your first six months some projects you'll work on include:

  • Assessing current equipment reliability, PM effectiveness, and engineering KPIs
  • Implementing a new CMMS software platform
  • Identifying and prioritizing capital investments to support production growth
  • Standardizing engineering documentation and technical standards
  • Developing a 12-24 month engineering roadmap aligned to commercial scale and regulatory readiness

We offer a full slate of employee benefits including:

  • Competitive salaries
  • Stock options
  • 401(k) matching
  • Medical, dental and vision coverage
  • Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
  • Employer paid life insurance and long term disability
  • Gym membership/recreational sports reimbursements

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