Jobs for People with MS: National MS Society

Project Engineer

Job Description

Support technical issues related to manufacturing and product quality. Develop new processes for plasma-derived therapies. Follow regulatory guidelines for process development and validation. Ensure lab equipment is calibrated and compliant. Design and plan scientific experiments for projects. Review and approve cGMP documentation. Lead process development and validation studies. Transfer process changes from Process Development (PD) to Manufacturing. Act as a liaison between PD and Manufacturing. Maintain and review process development Batch Records. Perform other tasks as assigned by PD Managers. Support Manufacturing, Engineering, and Quality Management with new processes and technology. Assist in process development and validation studies in a cGMP environment.

Responsibilities

• Support technical issues related to manufacturing and product quality

• Develop new processes for plasma-derived therapies

• Follow regulatory guidelines for process development and validation

• Ensure lab equipment is calibrated and compliant

• Design and plan scientific experiments for projects

• Review and approve cGMP documentation

• Lead process development and validation studies

• Transfer process changes from PD to Manufacturing

• Act as a liaison between PD and Manufacturing

• Maintain and review process development Batch Records

• Perform other tasks as assigned by PD Managers

• Support Manufacturing, Engineering, and Quality Management with new processes and technology

• Assist in process development and validation studies in a cGMP environment

Essential Skills

• 5-10 years experience in a cGMP manufacturing environment

• Equipment Qualification/Validation, and Commissioning

• cGMP Document Control

• Bachelors Degree in STEM field (Chemical or Mechanical preferred

• Project Management

Additional Skills & Qualifications

• CAPA

• Mechanical Drawings

• Investigations

• FDA

• Centrifuge

• Troubleshooting

Work Environment

Time spent on manufacturing floor, interacting with QA/QC/Production/Facilities, and own desk setup in engineering wing.

Pay and Benefits

The pay range for this position is $48.08 - $62.50/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)

Workplace Type

This is a fully onsite position in Boca Raton,FL.

Application Deadline

This position is anticipated to close on Mar 24, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.