Project Manager (Contract) - Blue Star Partners LLC

Job Posting: Project Manager

Location: Des Plaines, IL (onsite only)

Pay Rate: $50-$55/hour 

Duration: 1 Year with possible extension 

Type: W2 Contract (Must be authorized to work in the US; no sponsorships available)

Overview: We are seeking a highly motivated Project Manager to join our client in Des Plaines, IL. This onsite role requires expertise in the pharmaceutical or medical device industries and a strong understanding of Design Control principles. The hiring manager is looking for a candidate who can start as soon as possible to contribute effectively to ongoing projects.

Responsibilities

• Design Control Management: Oversee the implementation of design control processes throughout the product development lifecycle, ensuring compliance with FDA regulations and ISO standards.
• Cross-Functional Collaboration: Work closely with R&D, quality assurance, regulatory affairs, and manufacturing teams to ensure alignment on project objectives and deliverables.
• New Product Development: Support the development of new products by utilizing industry best practices and methodologies, from concept through to commercialization.
• Documentation and Reporting: Maintain accurate project documentation, including design history files, risk management files, and validation protocols, and ensure timely reporting of project status to stakeholders.
• Creative Problem Solving: Apply innovative thinking to overcome challenges and streamline processes while maintaining compliance with internal and external requirements.
• Training and Mentorship: Provide guidance and training to team members on design control practices and project management methodologies, fostering a culture of continuous improvement.
• Project Management: Utilize project management tools to track progress, manage timelines, and ensure that project milestones are met efficiently.

Qualifications

• Education: Bachelor’s Degree in business, engineering, science, information systems, or a closely related field is preferred.
• Experience: Minimum of 5 years of related work experience in the pharmaceutical or medical device industry, with a demonstrated track record of successful project management.
• Desirable: Master’s Degree (MBA or MS) is a plus but not essential.
• Certification: Project Management certification (e.g., PMP, CAPM) is preferred.
• Skills:
  • Strong knowledge of new product development methodologies, including Design Thinking, Stage-Gate processes, and Agile methodologies.
  • Excellent problem-solving skills, with the ability to creatively achieve objectives while ensuring compliance with regulatory standards.
  • Exceptional communication and collaboration skills to effectively liaise with cross-functional teams and stakeholders.
  • Proven ability to manage multiple projects simultaneously, demonstrating strong organizational skills and attention to detail.
  • Proficiency in project management software and tools (e.g., MS Project, JIRA, Trello) is advantageous.