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RCM Technologies, Inc.

Process Engineer

RCM Technologies, Inc., Raleigh, North Carolina, United States

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Senior Process / Equipment Engineer Location: RCM Technologies, Inc. (Philadelphia, PA). This role is a 1-year + contract.

Compensation:

Up to $85 hourly commensurate with experience.

RCM is seeking a Process/Equipment Engineer to work with our client, a leading biotech, focusing on several key areas in manufacturing. This role is crucial for ensuring an efficient implementation process for multiple types of equipment. The ideal candidate will bring experience leading, coordinating and managing teams (internal/external) throughout the installation and implementation process of manufacturing equipment and peripherals. The candidate will also be responsible for adhering to the timeline, tracking budget, and be well versed in stakeholder management. Strong understanding of cGMP regulations and safety standards are required as well as general process knowledge for the areas of work identified.

Responsibilities

Act as Process / Equipment Engineer (Owners Reps) in support of key workstreams focusing on biotech manufacturing.

Support end-to-end projects starting with design, working with end users, by confirming mechanical and automation detailed design through system delivery including system commissioning and qualification (RV/IV/OV/IQ/OQ/PQ, etc.), as necessary.

Develop scope and user requirements with stakeholders that will be used as the basis for detailed design developed by a third-party engineering design firm.

Hold meetings to review progress and resolve issues, as necessary, to ensure that project scope, end user requirements are being met, and impact to operations is minimized and well understood.

Identification and coordination of all tasks required to implement and prepare equipment for installation, qualification, production, project schedule, stakeholder, budget & escalation management, and adherence to client policies and procedures.

Project Assignments include one or more of the following: Compounding/ Formulation, solution preparation and compounding, including mixers, vessels, and filters. Component and Stopper Prep, component preparation, such as autoclaves, washers, stopper prep. Syringe fillers, automated syringe filling lines, ensuring accuracy and sterility. Auto-Inspection, automated visual inspection systems for filled syringes. Autoinjector Assembly, from component feeding to final assembly. Packaging, secondary packaging, including labeling, cartoners, and case packers.

This role will require travel to Philadelphia January through May weekly.

Qualifications

7+ years of Process Engineer Experience Required

Proven Track Record of Project Management.

Working knowledge of process engineering software packages.

Knowledge of process related standards.

Strong communication skills, interpersonal skills, and adeptness in conflict resolution and client interfacing/negotiation.

Strong understanding of cGMP and ISO standards.

Education & Certifications

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

Equal Opportunity Employer 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.

About RCM RCM Technologies, Inc. (Nasdaq: RCMT) is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.

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