Sr. Process Engineer - Assay ManufacturingBillerica, MAROLE SUMMARY:We are seeking a highly skilledSr. Process Engineer - Assay Manufacturing to lead the development, scale-up, and optimization of our diagnostic assay manufacturing lines. The ideal candidate will bridge the gap between R&D and commercial production, ensuring that all manufacturing processes are robust, scalable, and fully compliant with cGMP and ISO 13485 standards. You will be responsible for troubleshooting complex technical issues, implementing automation, and driving continuous improvement to ensure the highest quality of our diagnostic products.
WHAT YOU'LL DO:- Process Development & Scale-Up: Design, develop, and validate manufacturing processes for complex biological assays, moving products from R&D prototypes to full-scale commercial production.
- cGMP Compliance: Ensure all manufacturing activities, equipment, and documentation strictly adhere to current Good Manufacturing Practices (cGMP), FDA regulations, and ISO standards.
- Equipment Validation (IQ/OQ/PQ): Lead the installation, operational, and performance qualification of automated liquid handlers, plate washers, and other specialized assay manufacturing equipment.
- Technical Troubleshooting: Act as the subject matter expert (SME) for root-cause analysis of process deviations and yield excursions. Implement effective Corrective and Preventive Actions (CAPA).
- Documentation: Author and review Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and Process Validation protocols/reports.
- Continuous Improvement: Identify opportunities for cost reduction and efficiency gains through Lean Manufacturing, Six Sigma methodologies, and the integration of new technologies or automation.
- Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Supply Chain to ensure seamless technology transfers and product launches
BASIC QUALIFICATIONS:- Education: Bachelor's degree in Chemical Engineering, Bioengineering, Biotechnology, or a related scientific discipline. (Master's preferred).
- Experience: Minimum 8 years of experience in a process engineering role within a cGMP-regulated environment (e.g., IVD, medical device, or pharmaceutical industry).
- Regulatory Knowledge: Deep familiarity with FDA 21 CFR Part 820 and/or ISO 13485 requirements.
PREFERRED QUALIFICATIONS:- Direct experience with assay chemistry, reagent formulation, or diagnostic kit assembly
- Hands-on experience with automated manufacturing platforms and liquid handling systems
- Strong understanding of Statistical Process Control (SPC) and Design of Experiments (DoE).
- Experience with Six Sigma or Lean Manufacturing certification (Green/Black Belt).
- Proficiency in statistical software such as Minitab or JMP.
- Background in lyophilization processes or coating technologies.
- Strong project management skills and the ability to lead cross-functional teams.
EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES: - Strong judgment, accountability, and attention to detail in a regulated manufacturing environment.
- Effective communication and collaboration across technical and cross-functional teams.
- Strong problem-solving and decision-making skills with the ability to assess risk and recommend practical solutions.
- Ability to manage multiple priorities, adapt to changing business needs, and meet deadlines.
- Professionalism, sound judgment, and the ability to handle sensitive information with discretion.
- Continuous learning mindset with a focus on quality, process improvement, and operational excellence.
- Must be able to work in a cleanroom environment (ISO 7/8).
- Occasional lifting of equipment (up to 25 lbs) may be required.
- Adherence to strict gowning and safety protocols is mandatory.
- Work location: Billerica, MA (Onsite 5 days)
- Travel 10%
Pay Range: $100,000 - $120,000 per year
