Junior Manufacturing Engineer

Universal Diagnostics•Dallas, TX

62d

About The Position

We are seeking a motivated Junior Manufacturing Engineer to support daily manufacturing operations for our cfDNA-based diagnostic assay platform. This entry-level position is ideal for a detail-oriented, hands-on individual eager to learn in a fast-paced, regulated biotech environment. You will play a vital role in executing production tasks, maintaining equipment, and ensuring quality and compliance across manufacturing workflows. You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

Requirements

MS or BS degree in Bioengineering, Chemical Engineering, Molecular Biology, or related field.
0-2 years of experience in manufacturing, laboratory, or process engineering.
Familiarity with basic laboratory techniques, aseptic practices, and documentation standards.
Strong attention to detail and ability to follow written procedures accurately.
Foundational understanding of safety, GMP, and regulatory principles.
Reliable, organized, and committed to learning in a fast-paced environment.
Positive and proactive attitude with strong teamwork skills.
Effective communicator with solid problem-solving and time management abilities.

Nice To Haves

Certification or coursework in Lean, Six Sigma, or process improvement methodologies.
Exposure to reagent or diagnostic kit manufacturing, liquid handling, or scale-up operations.
Experience in aseptic processing or lyophilized product handling.

Responsibilities

Execute routine manufacturing activities in compliance with established SOPs and batch records.
Prepare reagents, buffers, and consumables according to specifications.
Operate, clean, and maintain laboratory and production equipment per defined schedules.
Record all data accurately and maintain complete, traceable documentation in accordance with GMP standards.
Perform basic calibration checks and assist with preventive maintenance programs.
Maintain work areas to meet 5S and safety standards, ensuring readiness for audits.
Promptly report equipment issues or maintenance needs to supervisors.
Complete all documentation following GDP (Good Documentation Practice) and GMP requirements.
Ensure all entries are legible, dated, and verified where required.
Support audit readiness and contribute to maintaining compliant laboratory environments.
Adhere to biosafety, chemical safety, and PPE requirements at all times.
Follow QMS procedures to maintain high product quality and data integrity.
Immediately escalate deviations, non-conformances, or safety concerns for resolution with Quality and Operations.
Communicate task progress, delays, or issues clearly to supervisors.
Collaborate with peers to maintain smooth production flow and continuous improvement.
Participate in departmental meetings, training, and improvement initiatives.
Contribute to a respectful, inclusive, and team-oriented culture.