Job Title: 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. Development activities will focus on transdermal and oral thin films, including mixing, coating, slitting, converting, and packaging. The development path includes product development, process feasibility, development, optimization, registration, and validation. Additionally, Quality Engineers will support equipment and facilities initiatives such as qualification and change control assessment, and improve current internal practices and procedures to enhance manufacturing documentation and standardize robust methodologies.

ResponsibilitiesSupport process development and design transfer from Research and Development to Commercial Production.Ensure products and processes meet regulatory and customer specifications.Focus on development activities for transdermal and oral thin films, including mixing, coating, slitting, converting, and packaging.Support equipment and facilities initiatives, including qualification and change control assessment.Improve manufacturing documentation and standardize robust methodologies.Essential Skills4+ years of experience in Medical/Pharma Capital Automated Equipment Validation.Experience in Change Control Assessment.Proficiency in Quality Engineering, Validation protocols, and automated equipment testing procedures.Experience with process validation and risk assessment.Knowledge of GMP, ISO, and manufacturing equipment.Familiarity with OQ, IQ, and validation testing.Additional Skills & QualificationsExperience in equipment qualification and validation.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 cGMP, ISO, ISPE, ANSI/ASQ standards and guidelines.Experience with regulatory agencies, filing pathways, and diversified product types.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).Experience with software validation.Strong skills in technical writing, including risk assessments, protocols, and reports.Work Environment

Monday - Friday, 8 AM - 5 PM. Onsite for the initial 3 to 6 months training period; then remote potential up to 2 days per week. The position requires working in a manufacturing/operations environment, with time spent on the floor.

Pay and Benefits

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

Medical insurance
HSA
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 Feb 21, 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.