Junior Process Engineer

LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include Maine Standards Company, Sera Care Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US.

Each day, our world‑class staff, scientific expertise, operational efficiency, and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes— from the widely adopted and established through to cutting‑edge NGS and precision diagnostics.

The Junior / Associate Process Engineer provides hands‑on technical and execution support for manufacturing processes, validations, and investigations at the site. The role focuses on execution‑level process engineering activities, including data collection, validation support, manufacturing floor support, and troubleshooting, particularly during process transfers, integrations, and early‑phase manufacturing activities. This position supports efficient workload distribution within process engineering while enabling development of practical, hands‑on process expertise.

To perform this job successfully, an individual must be able to capably perform each of the following essential duties:

• Support equipment, utility, process, labeling, and shipping validations, including study setup, execution, data collection, documentation, and report completion across short‑ and medium‑term project timelines.
• Perform historical data extraction, compilation, and preliminary analysis to support CAPA, NCR/OOS investigations, trending, and process improvement activities.
• Provide hands‑on manufacturing floor support during routine production, including real‑time process monitoring, issue identification, and troubleshooting in laboratory and manufacturing environments.
• Assist with process integration and stabilization activities, including increased troubleshooting and investigation support during early operational phases under established procedures.
• Support process optimization and continuous improvement initiatives by identifying execution‑level opportunities and implementing approved changes under supervisor guidance.
• Prepare and maintain validation protocols, reports, memos, batch documentation, and investigation records in accordance with GMP and internal requirements.
• Collaborate routinely with Manufacturing, Quality Control, Quality Assurance, and Process Engineering teams to support operations while minimizing disruption to core production and compliance activities.
• Execute assigned work in accordance with SOPs, work instructions, GMP, safety, and PPE requirements, escalating issues as appropriate.

Perform other duties as assigned to meet business needs.

Essential Knowledge and

Qualifications:

Required

• Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related technical field.
• 0–3 years of experience in a GMP‑regulated manufacturing or laboratory environment
  .
• Familiarity with manufacturing documentation, batch records, and data handling.
• Basic understanding of statistics and data analysis (e.g., Excel‑based analysis).
• Ability to work effectively in manufacturing and laboratory environments.

Preferred…