Sr. Process Engineer

Full Time Contract

Role: Senior Process / Equipment Engineer

Compensation: Up to 85/hr. Commensurate with experience

Location: Raleigh-Durham Area / Hybrid

Length of contract: Long term 1 year

Position Description:

RCM is looking for a Process/Equipment Engineer for our biotech client. This is a critical role with responsibility for the end-to-end installation of equipment from supplier through production in a large-scale manufacturing environment. You will be responsible for ensuring that equipment and all related peripherals are implemented according to best practices, the client’s policies and regulatory standards, and established timelines/budget.

Project Assignments will involve Autoinjector and Autoinjector Assembly. Auto Injector experience is required.

• Process and Equipment Leadership: Act as the owner's representative Equipment/Process
• Process and Equipment Management: Provide technical ownership for the installation and development of all supporting processes and deliverables, coordinating with suppliers and third parties as required.
• Regulatory Compliance and Quality Assurance: Ensure all processes and equipment adhere to Good Manufacturing Practices (GMP).
• Project and Technical Leadership: Manage project from design through implementation, support technical transfers, and collaborate with cross-functional teams to resolve issues.
• Project Management: Lead internal and external teams to manage the safety, quality, cost, and schedule for all equipment projects, ensuring timely and on-budget delivery.
• Problem-Solving: Proactively anticipate and solve problems to ensure commitments are met, and projects are completed on time, in full and on budget

Qualifications:

• 7 years of experience as a Process/Equipment Engineer, with a proven track record of managing projects in a regulated manufacturing environment.
• In-depth knowledge of bioprocessing and equipment, specifically in areas such as compounding, aseptic filling, and packaging.
• Strong understanding of cGMP and ISO standards, with a background in equipment validation and process qualification.
• Demonstrated ability to manage project timelines, budgets, and stakeholders effectively.
• A proactive, results-oriented approach to identifying and resolving complex technical issues.
• Excellent communication and interpersonal skills, with the ability to lead teams, negotiate with vendors, and align diverse stakeholders.
• Proficiency in process engineering software packages and a working knowledge of process-related standards.

Education & Certifications:

• Bachelor's degree in Mechanical, Chemical, or Biomedical Engineering.

Equal Opportunity Statement:

RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Pay Transparency:

RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.

Disclaimer:

This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

About RCM:

RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.