Seeking an Equipment Validation Engineer

Job Description

Provide ongoing Quality Engineering support to process development and design transfer from Research and Development to Commercial Production. Ensure products and processes conform to regulatory filing requirements and customer specifications. Product types will include pharmaceutical and medical devices, with a focus on transdermal and oral thin films, including mixing, coating, slitting, converting, and packaging. Development activities will cover product development, process feasibility, optimization, registration, and validation. Additionally, provide insight and support to equipment and facilities initiatives such as qualification and change control assessment, improving manufacturing documentation and standardizing robust methodologies.

Responsibilities

• Support process development and design transfer from R&D to Commercial Production.
• Ensure products and processes meet regulatory filing requirements and customer specifications.
• Focus on transdermal and oral thin films development, including mixing, coating, slitting, converting, and packaging.
• Involve in product development, process feasibility, optimization, registration, and validation.
• Provide support to equipment and facilities initiatives, including qualification and change control assessment.
• Improve current internal practices and procedures to enhance manufacturing documentation.
• Standardize robust methodologies for manufacturing processes.

Essential Skills

• 4 years of experience in Quality Assurance and Medical/Pharma Capital Automated Equipment Validation.
• Experience in equipment qualification and validation work.
• Experience with large-scale automated equipment (e.g., air handlers, cartoning lines, tableting equipment).
• Familiarity with facility qualifications, including clean room requirements and regulatory specifications.
• 5 years of quality experience in a regulated pharmaceutical, biopharmaceutical, or medical device position.
• Knowledge of manufacturing equipment and processes, increasing with each level.
• Working knowledge of cGMP, ISO, ISPE, ANSI/ASQ standards and guidelines.
• Experience with regulatory agencies, filing pathways, and diverse product types.

Additional Skills & Qualifications

• Experience leading qualification efforts on equipment, systems, and software.
• Knowledge of Good Automated Manufacturing Practice (GAMP).
• Experience with Continued Process Verification reports and Process Validation reports.
• Proficiency in statistical software (e.g., Minitab) is preferred.
• Experience with software validation is a bonus.
• Strong skills in technical writing, including risk assessments, protocols, and reports.

Pay and Benefits

The pay range for this position is $75000.00 - $95000.00/yr.

Medical insurance, HSA set up, Dental Insurance, Group Life Insurance, 410K plan, Vacation time, PTO, Paid time off for volunteer work, short and long-term disability.

Workplace Type

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

Application Deadline

This position is anticipated to close on Apr 29, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $75,000 - $95,000