Validation Engineer II/III/Sr

Jubilant HollisterStier LLC; Spokane (WA); On-site; USD 89,000 - 163,000; Full time

Benefits offered by this job

Medical, Dental & Vision

FSA/HSA

Life & AD&D Insurance

Disability Insurance

Employee Assistance Program

Job summary

Jubilant HollisterStier LLC in Spokane, WA is a leading pharmaceutical manufacturer seeking a Validation Engineer to advance GMP-compliant process validation across CDO activities, including sterile vials, lyophilization, and aseptic processes. The role collaborates with multiple departments to drive improvements and regulatory compliance.

Levels range from II to Senior, with yearly compensation from $89,300 to $163,300 and benefits starting on day one.

Qualifications

• Bachelor of Science required in mechanical, chemical, manufacturing or similar engineering discipline.
• 3+ years for Engineer II; 5+ for Engineer III; 7+ for Senior Engineer in pharmaceutical manufacturing or GMP operations.
• Knowledge of sterilization, lyophilization, aseptic processing, mixing and cleaning processes.
• Familiarity with pharmaceutical process equipment, validation principles and GMP systems.
• Awareness of project management concepts and ISPE Baseline Guides.

Responsibilities

• Provide technical support for CDO and engineering opportunities, including process characterization and improvements.
• Assist in regulatory compliance and documentation for facilities, equipment, and processes.
• Manage or support multi-department projects using standard project management guidelines.
• Collaborate with internal/external customers and vendors to advance initiatives.
• Develop detailed specifications and scope inputs for A&E firms and contractors.

Skills

Sterilization

Lyophilization

Aseptic processing

Mixing operations

Cleaning processes

Process equipment

Validation

GMP systems

Project Management

Education

Bachelor of Science (Mechanical/Chemical/Manufacturing)

Tools

Microsoft Project

PowerPoint

Job description

Join a Leader in Pharmaceutical Manufacturing - And Build What's Next

As Spokane's Largest Manufacturing Company, Jubilant HollisterStier LLC is a well-established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

We are nationally recognized for our expertise in producing sterile injectable vials and lyophilized products, and our Allergy business is a global leader in allergenic extracts that support treatments for allergies and asthma. Jubilant HollisterStier is proudly part of the global, Jubilant Pharma family. established force in the pharmaceutical and biopharmaceutical industries, providing a complete range of manufacturing services that support lifechanging medicines around the world.

If you are someone who thrives on solving complex problems, improving systems, and building real solutions, you'll feel at home here. At Jubilant HollisterStier, your ideas matter - and your impact is felt globally.

Why builders choose us:

• Immediate impact: Your work directly supports essential medicines and allergenic therapies used worldwide.
• Benefits start on day one: Medical, Dental, Vision, FSA/HSA, Life, AD&D, and Disability benefits begin immediately because your well-being shouldn't have a waiting period.
• A career you can grow: We provide opportunities for growth, promotion, and annual raises, with midpoint compensation reserved for high performance and longevity.
• A culture of improvement: We value people who thrive on continuous improvement, innovation, and hands on contribution.
• A stable industry leader: Backed by Jubilant Pharma, we pair long term stability with forward looking innovation.

If you want to build something meaningful with a team that values your drive, skills, and ideas - you belong here.

Job Description:

The Validation Engineer provides pharmaceutical process validation knowledge and technical engineering activities within pharmaceutical Commercialization, Development, & Optimization (CDO), with focus areas that may include steam sterilization, lyophilization, aseptic processing, mixing operations, cleaning processes, and related GMP manufacturing systems. The engineer will also contribute technical direction for CDO opportunities and exhibit clear communication skills with all levels of employees and external customers.

Responsibilities may vary by level and assignment. The accountabilities below describe the general scope of work for the job profile and are not intended to be a comprehensive list of all duties that may be assigned.

• Provides technical support for CDO and engineering opportunities, including process characterization, process boundary testing, process compliance upgrades, cost reduction, contract manufacturing, process improvements, facility/utility impacts, construction projects, and related technical initiatives.
• Through education and experience, applies pharmaceutical engineering validation judgment to evaluate technical feasibility, define engineering requirements, support process/equipment troubleshooting, and recommend practical solutions for CDO-related opportunities and pharmaceutical systems.
• Is responsible for assistance in contributing knowledge of regulatory requirements for the facility, equipment, and processes to ensure compliance to local, state, federal and international regulatory agencies.
• With supervision/assistance, supports and manages assigned CDO and engineering initiatives in a manner that is compliant with the "Project Management Guidelines" system. This system includes methods for scheduling, budgeting, meeting management, teamwork, communication, and documentation of a multi-departmental project team.
• Must work effectively with various internal and external customers on a daily basis. Internal customers may include departments such as CDO, Tech Services Engineering, Maintenance, Quality Assurance, Manufacturing, Validation, Finance, etc. External interactions will include officials from local, state or federal regulatory agencies, A&E firms, construction firms, vendors, equipment manufacturers, etc. 6. Participates in building compliance into manufacturing processes to meet both short-term and long-term company objectives as defined by upper management. 7. Development of detailed specifications, scope inputs, and RFQs to be used by A&E firms, contractors or equipment manufacturers, vendors, or other technical partners for initiatives being pursued by the company. 8. Responsible for using systems of engineering documentation required by regulatory agencies and in compliance with generally accepted engineering guidelines, SOPs, or quality standards.

Qualifications:

Required:

For All Levels:

• Bachelor of Science; Major: Mechanical, Chemical, Manufacturing, or similar engineering discipline.

Specific Level Requirements:

• Validation Engineer II:
  • Typically, 3+ years of relevant experience in pharmaceutical manufacturing, validation, engineering, technical services, or related GMP operations.
  • Working knowledge of Sterilization, lyophilization, aseptic processing, mixing operations, and cleaning processes.
  • Working Knowledge of Pharmaceutical process equipment, validation principles, and GMP manufacturing systems.
  • General Awareness of Project Management.
  • General Awareness of ISPE Baseline Guides.
• Validation Engineer III:
  • Typically, 5+ years of relevant experience in pharmaceutical manufacturing, validation, engineering, technical services, or related GMP operations.
  • Working Knowledge to Functional Expert of Sterilization, lyophilization, aseptic processing, mixing operations, and cleaning processes.
  • Working Knowledge to Functional Expert of Pharmaceutical process equipment, validation principles, and GMP manufacturing systems.
  • Working Knowledge of Project Management.
  • General Awareness to Working Knowledge of ISPE Baseline Guides.
• Senior Validation Engineer:
  • Typically, 7+ years of relevant experience in pharmaceutical manufacturing, validation, engineering, technical services, or related GMP operations.
  • Functional Expert in Sterilization, lyophilization, aseptic processing, mixing operations, and cleaning processes.
  • Functional Expert in Pharmaceutical process equipment, validation principles, and GMP manufacturing systems.
  • Working Knowledge to Functional Expert of Project Management.
  • Working knowledge of ISPE Baseline Guides.

Preferred:

• Experience in Validation, process equipment, aseptic processing, sterilization, lyophilization, or cleaning processes.
• Experience in Technical troubleshooting or process improvement in a GMP manufacturing environment.
• Experience in Microsoft Project & Microsoft PowerPoint Project.
• Experience in Management/Project Engineering.
• Experience in Pharmaceutical Facility/Systems.

Working Environment:

• Work in classified/aseptic areas.
• Work in confined spaces.
• Potential exposure to allergens.
• Extended periods of sitting or standing.
• Ability to lift 40 lbs. unassisted.

Location: Spokane, WA - On Site, Full-Time

Shift: Monday-Friday 8am-5pm

Compensation & Benefits That Start on Day One - Because Your Well Being Matters

Hiring Wage:

Level II: $89,300 - $142,800 annually, with opportunities for growth, promotion, and annual raises.

Level II/Sr.: $102,100 - $163,300 annually, with opportunities for growth, promotion, and annual raises.

At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.

Starting on your first day, you receive:

• Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Unlock Your Potential

Jubilant HollisterStier is an EEO/AA Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

We are committed to enhancing value for customers and stakeholders by delivering innovative and economically efficient solutions, always with care for the environment and society.