Careers

Covaris is a mid-sized biotechnology company looking for Manufacturing, Quality, or Laboratory scientist with excellent laboratory technique and experience in design and execution of scientific experiments. The role will require day to day responsibilities in both Manufacturing and Quality Departments. Ideally, the individual should have at least 5-10 years of experience in a laboratory or reagent manufacturing environment and should have familiarity with quality systems, standard operating procedures, good documentation practices, experimental design, and statistical analysis techniques.

The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.

Major responsibilities in the Reagent Manufacturing area will include:

• Produce, package and label solid and aqueous buffers
• Execute and record QC on a batch-to-batch level and monitor results for quality and consistency using statistical analysis
• Maintain Certificates of Analysis on incoming raw materials
• Maintain completed formulation sheets for KPI monitoring and process improvements
• Responsible for maintaining an RNase-free work area when making or dispensing specific solutions for kits devoted to the analysis of RNA.

Major responsibilities in the Quality and all Manufacturing areas (Instrument, Consumable, Accessories, and Reagent) will include:

• Writing and establishing QC procedures and documentation for product consistency
• Understand and execute the required document control forms (DCN’s) for the implementation of changes to and new products
• Assist in design and execution of product shelf life, guard-banding, and V&V studies
• Develop and implement Standard Operating Procedures for manufacturing and R&D.

Time permitting, work with R&D and Applications on specific projects to help generate the necessary data for product commercialization.

In addition to the essential responsibilities listed above, the employee may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

• The individual should have a minimum of a BS degree in biology, chemistry, biochemistry or equivalent and 5-10 years of experience in a working academic or industrial laboratory.
• Having experience in a manufacturing environment with a robust quality system such as GMP, GLP, ISO 9001 or ISO 13485 is preferable.
• Familiarity with computer software such as Microsoft Excel, Word and PowerPoint.
• Familiarity with SharePoint and databases, such as ERP systems and EQMS
• Ability to write reports, business correspondence, and standard operating procedures.
• Ability to effectively present information and respond to questions from managers and peers.
• Detail oriented.
• Have the flexibility to work in both a team environment and as an individual contributor.
• Must be willing to take responsibility for getting the required tasks completed in a timely manner.

Covaris is committed to the spirit and the letter of the Americans with Disabilities Act. All requirements are subject to possible modification to reasonably accommodate otherwise qualified individuals.

This is an exciting opportunity for someone who enjoys working in a fast-paced environment driving multi-disciplinary project teams. The Project Manager (PM) will be part of the Covaris Engineering organization and will oversee new and ongoing engineering projects. The Engineering Org is comprised of mechanical, software, and electrical engineers – who are engaged in a wide variety of activities from new product development (instruments, software, and consumables) and product feature enhancements, to Manufacturing & Field support (troubleshooting, production line-automation, root cause analyses, etc.). Projects include major cross-functional initiatives (e.g., the development of new instruments) to smaller short-term efforts that involve relatively few tasks. The PM will be responsible for determining the resources and budget required to execute a project and will generate/own project plans and schedules, as well as identifying risks and mitigation plans. He/she will work with Marketing, Sales, Applications (and other groups) to ensure user requirements are rational, measurable, clearly articulated, documented, and prioritized. The PM will not necessarily drive all Engineering projects, but rather will work with others on the team to ensure that all Engineering projects are planned, executed (following applicable processes) and reported on in a consistent manner. Another important function is communicating to stakeholders and other groups as needed to ensure there are no surprises and information breakdowns. This is a highly visible position that reports directly to the VP of Engineering.

The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.

• Project planning (budget, resources, WBS, schedule) and execution – meeting deliverables on time within budget
• Scope definition and creep control
• Ensure appropriate processes are followed and required documentation is generated
• Identify and communicate risks and develop mitigations plans to drive risks down early
• Develop high-level dashboard that conveys the status, open issues/actions, risk level (etc.) of all significant Engineering projects and provide routine updates
• Generate project Gantt Charts for the more significant projects that clearly show milestones, task dependencies, and critical path
• Implement best PM practices and harmonize Engineering projects, regardless of who drives them
• Lead multidisciplinary project teams
• Chair cross-functional project meetings as appropriate to review status, task assignments, and ensure all stakeholders (across the company) are informed
• Work with vendors as appropriate to obtain material cost and timeline information

In addition to the essential responsibilities listed above, the employee may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

• BS in engineering or related field, w/ 5+ years of post-college experience, or MS w/ 3+ years of experience, including 2 years (minimum) as a technical Project Manager – planning and executing integrated HW/SW development projects and driving cross-functional teams
• PMBOK familiarity / PMP certification preferred
• Self-starter
• Familiar with Waterfall and Agile development methodologies
• Able to travel up to 10% to domestic customers and vendors
• Working knowledge of ISO9001:2015 compliant phased (stage gate) development processes
• Familiarity with ISO 13485 and Med Device development & certification desired
• Comprehensive understanding of mechanical, electrical, software, and firmware development and systems integration & engineering – highly desired
• Familiarity with CE/UL/CSA/EU Regulatory Requirements and processes desired

• Excellent People & Leadership Skills – Must be capable of leading teams of technical personnel, managing conflict resolution, and customer (internal/external) expectations
• Exceptional Organizations Skills – able to organize and prioritize multiple concurrent tasks and projects
• Scope/Requirements Analysis – Must be capable of working with customers (internal/external) to translate wants and needs into scope and requirements
• Project Cost & Schedule Estimation – Must be capable able to develop estimates for task duration and cost
• Problem Solving – able to break down and solve complex problems
• Communication Skills – Must have excellent written, verbal, and presentations skills
• Schedule/Budgets – Must be capable of developing a WBS and translating into project schedule, and able to develop project budgets and resource requirements
• MS Office and Project – Proficiency with MS Word, Excel, Power Point, and Project
• Risk Management – Must be able to identify project risks and develop mitigation plans

• Systems engineering
• Comfortable with MS Teams
• Familiar w/ structured problem solving methods, such as A3, Fishbone, Six-Step, etc..
• Experience with Jira
• Working knowledge of PERT charts, Monte Carlo Simulation/Analysis, FMEA, DOE, DFM
• Familiarity with Scrum and Kanban development methodologies
• Basic understanding of tooled plastic part fabrication processes
• Experience developing complex electro-mechanical devices
• Six Sigma certification
• Background in biotechnology – familiarity with common instrumentation (NGS, PCR, Rt-PCR, common DNA sequencers, etc.), workflows (end-to-end for genomics, DNA sequencing, proteomics, epigenomics, etc.), and processes (including sample prep and purification, enzymatic fragmentation, lysing, etc.)

• Covaris is committed to the spirit and the letter of the Americans with Disabilities Act. All requirements are subject to possible modification to reasonably accommodate otherwise qualified individuals.