Process Engineer - API CDMO - Rhode Island

As a vital member of the team, the Process Engineer leads the design, installation, and implementation of processes and equipment to ensure the safe, compliant, and efficient production of small molecule active pharmaceutical ingredients (APIs) in a GMP environment.Client DetailsOur client is a rapidly growing global CDMO within the biotechnology field, dedicated to establishing a strong foothold in the US market. Renowned for its expertise in Biologics, Clinical Research, Bioanalytical Sciences, DMPK, Cell and Gene Therapy, and other critical areas, this company has garnered acclaim for its outstanding service, fostering strong client relationships and repeat business in the US.DescriptionSupport technical transfer of new processes from concept to product delivery.Define scale and equipment fit for new processes.Design and install new equipment or modify existing equipment for new processes.Manage process safety concerns and implement Process Safety Management (PSM).Perform qualification and validation activities as per the site master plan.Generate project documentation and provide training.Assist in project management activities.Execute capital and expense projects at the Coventry site.Provide technical support during production activities.Resolve issues and ensure safe and compliant process execution.Own change controls, quality events, CAPA, etc., within the quality system.Participate in team safety meetings.Complete engineering-related action items.Administer the engineering document repository (AutoCAD Vault).ProfileProven background in manufacturing, engineering, or project management related to pharmaceutical ingredients, specialty chemicals, or fine chemicals.Comprehensive experience in batch manufacturing involving various unit operations and related equipment.Profound knowledge of cGMP manufacturing practices.Expertise in both project engineering and process engineering.Familiarity with cGMPs and FDA regulations.Knowledge of OSHA Process Safety Management Standard and other pertinent codes and regulations.Job OfferCompetitive base salaryFulfilling career roleVigorously growing CDMOAmple growth opportunities!

Desired Skills and Experience

• Proven background in manufacturing, engineering, or project management related to pharmaceutical ingredients, specialty chemicals, or fine chemicals.
• Comprehensive experience in batch manufacturing involving various unit operations and related equipment.
• Profound knowledge of cGMP manufacturing practices.
• Expertise in both project engineering and process engineering.

Familiarity with cGMPs and FDA regulations.

• Knowledge of OSHA Process Safety Management Standard and other pertinent codes and regulations.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.