Validation Manager

Description

We are seeking an Engineering & Validation Engineering Manager to lead a multidisciplinary team responsible for process engineering and validation across development and GMP operations. This leader will oversee strategy through execution, supporting R&D, process development, tech transfer, manufacturing, and quality functions in a dynamic small-company environment.

Team & Leadership

- Lead, mentor, and develop a 7-person team of validation and process engineers.

- Establish engineering and validation standards, templates, and best practices.

- Create a high-performance culture centered on safety, quality, and continuous improvement.

Development (R&D/PD/Scale-Up)

- Partner with R&D and Process Development to design scalable, QbD-aligned processes.

- Lead engineering studies and DoE to support process characterization and scale-up.

- Specify and implement development-phase equipment; author and approve URS and risk assessments.

- Drive tech transfer plans and readiness, including documentation packages and success criteria.

- Contribute to CMC filings with technical narratives and validation strategies.

GMP Operations (Clinical & Commercial)

- Own the site Validation Master Plan and validation lifecycle for equipment, utilities, and processes.

- Oversee cleaning validation, sterilization validation, and environmental monitoring qualification.

- Lead risk assessments, change controls, deviations, and CAPAs.

- Support PPQ campaigns, CPV, and process capability monitoring.

- Ensure compliance with FDA, ICH, and data integrity expectations.

Capital Projects & Reliability

- Partner with Facilities/Metrology on equipment reliability and maintenance strategies.

- Lead URS development, vendor selection, FAT/SAT, commissioning, and qualification.

- Manage small to mid-scale capital projects including scope, budget, and schedule.

Documentation & Systems

- Review and approve validation protocols, reports, and SOPs.

- Improve digital tools and systems supporting validation lifecycle management and CPV.

Skills

Validation, pharmaceutical industry, Lean manufacturing, Process improvement, Validation testing, Process engineering, Continuous improvement, Process validation, Validation protocols, Pharmaceutical, Six sigma, Equipment validation, Quality assurance, capa, gmp environment, fda compliance, iso 13485

Additional Skills & Qualifications

Required

- BS in an engineering discipline (Chemical, Mechanical, Biomedical, or related, advanced degrees is a plus)

- 8 years in pharmaceutical/biotech engineering with 3 years managing engineers.

- Expertise in risk-based validation, PPQ, and process engineering.

- Strong knowledge of FDA, QMSR/ISO 13485, EMA, ICH guidelines including 21 CFR 210/211 and Annex 15.

- Experience with tech transfer, scale-up, and cross-functional collaboration.

Preferred

- Experience in biologics, pharmaceuticals, or aseptic operations.

- Experience with Computerized System Validations and CPV statistical methods.

- Lean/Six Sigma or PMP certification.

- Experience working in a small biotech or startup environment.

This is a Contract to Hire position based out of Saint Paul, MN.

The pay range for this position is $57.00 - $72.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Saint Paul,MN.

This position is anticipated to close on Apr 14, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $57 - $72