Biomedical Process Engineer (Aseptic Processing & Validation)

Biomedical Process Engineer (Aseptic Processing & Validation)

Location:

Greater Boston Area, MA Job Type:

Full-Time Role Overview We are seeking a highly motivated and versatile Biomedical Process Engineer to join our team. In this hybrid role, you will be the technical bridge between process development, manufacturing, and quality. Focusing on our Class III medical device portfolio, you will be responsible for scaling, optimizing, and maintaining our aseptic fill and finish processes. Additionally, working under the strategic direction of our external validation consultants, you will draft, execute, and report on the validation of our clean room environments and process equipment.

Key Responsibilities Process Engineering & Scale-Up:

Lead the design, optimization, and scale-up of aseptic processing and sterile fill/finish manufacturing lines. Develop and implement process parameters for viscous filling, sterilization, and single-use systems specific to Class III medical device manufacturing. Troubleshoot equipment failures, process deviations, and environmental monitoring excursions, utilizing structured root-cause analysis. Draft and revise Standard Operating Procedures (SOPs), work instructions, and batch records for manufacturing operators.

Validation & Quality Assurance:

Collaborate with external validation consultants to translate high-level Master Validation Plans into actionable, on-the-floor testing protocols. Author, review, and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for cleanrooms and manufacturing equipment (e.g., autoclaves, isolators, fill lines). Coordinate and execute process simulations (media fills) and sterilization validations in compliance with industry standards. Write comprehensive validation summary reports, managing any deviations or non-conformances that arise during testing.

Cross-Functional Collaboration:

Act as the primary liaison between R D, Quality Assurance, external consultants, and floor operators to ensure seamless tech transfer and process compliance. Ensure all engineering and validation activities strictly adhere to

FDA 21 CFR

Part 820, ISO 13485, and

ISO 14644

standards. Why Join Us? Join a team dedicated to advancing healthcare through innovative technology. The biomedical devices of the Helios Group of companies have positively impacted patients' lives for over two decades, and we are committed to maintaining its legacy of excellence. We offer a collaborative and inclusive work environment, competitive compensation, and opportunities for professional growth. We are an equal-opportunity employer and encourage candidates of all backgrounds to apply. Candidates must be legally authorized to work in the United States without requiring future visa sponsorship (e.g., H-1B, F-1 OPT, etc.) at the time of hire or at any point in the future. This role does not offer sponsorship for work authorization.

Qualifications:

Required Qualifications & Experience Education:

Bachelor s or Master s degree in Biomedical Engineering, Bioengineering, Manufacturing Engineering, Chemical Engineering, Mechanical Engineering or a closely related discipline.

Experience:

3 to 6 years of hands-on process engineering and validation experience within the medical device, pharmaceutical, or biotechnology industries.

Regulatory Knowledge:

Direct experience working with Class III medical devices is highly preferred. Must possess a deep understanding of

FDA 21 CFR

Part 820, ISO 13485, and Good Documentation Practices (GDP).

Technical Expertise:

Proven background in aseptic processing, clean room environmental monitoring (ISO 14644), and sterile fill/finish operations.

Validation Skills:

Strong technical writing ability with a track record of successfully drafting and executing

IQ/OQ/PQ

protocols and summary reports.

Desired Attributes Agility:

Ability to seamlessly pivot between hands-on mechanical troubleshooting on the manufacturing floor and rigorous technical writing at a desk.

Coachable:

Highly receptive to guidance from senior validation consultants, with the ability to execute their strategic plans independently.

Communication:

Exceptional cross-functional communication skills, capable of explaining complex engineering challenges to non-technical stakeholders.