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Principal Automation Technology Engineer. in Cambridge, Massachusetts

About Affinivax

Affinivax is a Cambridge-based clinical-stage biotechnology company with a novel, next-generation approach to the development of vaccines and immunotherapies targeting infectious and other immune-mediated diseases. This novel and highly efficient vaccine technology – called Multiple Antigen Presenting System (MAPS) – enables the high-affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response.Our vision is to take a major step forward in vaccine innovation to prevent and combat a wide range of infectious and other immune-mediated diseases, protecting infants and adults in our communities and making a meaningful impact on global public health. Affinivax is focused on developing vaccines for the most challenging bacterial infections, with a goal of improving upon existing vaccines and providing solutions for where there are no vaccines or prevention strategies available today.

The role…

Affinivax has an exciting new opportunity for a highly motivated individual to own and oversee the automation program including the operational technology (OT), infrastructure, equipment, administration of GMP software packages and data integrity practices to support all GMP systems including those used in Manufacturing, QC and utilities for a 10,000 ft2 commercial pneumococcal vaccine manufacturing facility. This will include design, specification, directing and managing vendors, system and software installation, troubleshooting, qualification, and ongoing maintenance of automated systems and equipment. The Automation Engineer provides technical support and accountability for the automated execution of operational activities and administration of software packages that are critical to the success of our business. In this role you must be able to identify critical interfaces between building and equipment systems; interpret P&IDs, wiring diagrams, facility/equipment drawings, and equipment specifications to determine automation strategies in a GMP manufacturing facility; and effectively perform troubleshooting and repair activities (I&C) when required. Position level is dependent on experience.

You will have the opportunity to…

  • Provide technical leadership and direct support in the execution and delivery of the OT elements of equipment and software during project implementation and throughout the equipment lifecycle

  • Identify, design, source, build, install, program, configure, commission, and validate automated solutions using qualified contract support as needed

  • Design, specify, build, commission and validate the data center hardware infrastructure, network, and core configuration using qualified contract support as needed

  • Generate URS/FRS documentation from collaboration with key stakeholders to determine automated system requirements

  • Enforce and execute appropriate Affinivax security practices for system robustness and data integrity

  • Support Computer Systems Validation (CSV) activities: Test Protocols, Change Requests etc.

  • Ensure adherence and compliance with industry guidance and regulations (e.g., 21 CFR Part 11, EudraLex Annex 11, IQ7, ISPE GAMP5, etc…) for automated systems

  • Provide technical solutions driving to address root cause for a wide range of process, utilities, building, and networking challenges associated with automated systems

  • Collaboratively work with IT and other internal and external partners to identify integration requirements, resolve issues, and improve site performance

  • Provide support daily for BMS, EMS, SCADA, Utility Controls, Process Controls, and GMP data archiving and retrieval including GMP reports for quality

  • Maintain life cycle management of automated system and documentation within applicable procedural documents

  • Develop, revise and maintain Automation Program policies, procedures, forms, documentation and files

  • Establish programs and monitors to ensure back up and restoration of data occurs

  • Provide Subject Matter Expert (SME) function for CAPAs, Deviations and Change Controls

  • Create and revise maintenance procedures and spare parts assessments for automation systems

  • Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations, and industry codes

  • Knowledge of GMP practices utilized in bulk drug and vaccine manufacturing environment

  • Support development of automation standards and specifications

  • Identify opportunities to improve existing processes, equipment, systems, and infrastructure

  • Serve as SME to provide and present information during internal or regulatory inspections

  • Manage budgets and provide input to annual budget development

  • Serve as equipment and software system administrator to manage software applications, licensing, and user accounts

    Who you are and what you bring to the team…

  • Bachelor’s Degree, preferably in science or engineering; Master’s Degree in similar field preferred

  • 12+ years in the GMP biotechnology /pharmaceutical industry, of which at least 4 years of relevant automation engineering experience

  • Experience with implementation and operation of process control systems including SCADA required

  • Strong organizational, prioritization, technical, and mechanical skills as well as experience in a GMP & GAMP environment are preferred

  • Strong communication skills, both verbal and written, with attention to detail with all levels of an organization

  • Demonstrated project leadership skills and the ability to develop effective working relationships with cross-functional working teams

  • An independent self-starter with the ability to implement process and/or system improvements

  • Able to influence and work well with others in a proactive and constructive manner

  • Ability to anticipate operational issues and proactively recommend mitigations/solutions

  • High-level proficiency with MS Office products (Word, Excel, Outlook, and Power Point)

  • Working experience in project management and coordination associated with the execution of capital projects in a cGMP regulated environment

  • Experience with design and operation of industrial data historian and alarm notification systems

  • Experience with virtual machines

  • Experience with data center design, setup and maintenance

  • Experience with Industrial security standards

  • Experience with PLC coding, installation, and support including but not limited to Allen Bradley

  • Experience with BMS and EMS systems (Johnson Controls and Hanwell preferred)

  • Understanding of instrumentation, electrical and wiring standards

  • Understanding of network architecture including firewall and switch configuration and virtualized environments

  • Understand industry standard automation communication protocols like: HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC and Modbus TCP/IP

  • Familiarity with analytical equipment such as balances, pH meters, , filter integrity testers, etc.

  • Experience with current trends in automation and instrumentation

  • Experience with data integrity, specifically the understanding of FDA Part 11 and European Annex 11 requirements and experience applying these standards to the qualification of automation systems

  • Able to effectively manage the automation lifecycle of controls components

  • Familiarity with processing systems for pneumococcal vaccine Drug Substance manufacturing

  • Experience with the establishment and utilization of risk assessment systems

  • Experience with critical utility required and non-GMP utility systems a plus

  • Experience in automation related system commissioning and validation in GMP facilities is required

  • Must be able to develop, draft and correct preventative maintenance procedures for technical equipment

  • Subject matter expert in all site automation systems

    What We Offer:

  • Competitive compensation

  • Medical and Dental plans (BCBS), employer-paid at 85%

  • Vision Insurance, employer-paid at 100%

  • Life Insurance, Short- and Long-Term Disability

  • Flexible Spending Accounts/Health Savings Accounts

  • Wellness Benefits

  • 401(k) Plan with a 4% match

  • Tuition Reimbursement

  • Generous PTO package

  • 11 paid holidays, plus Holiday Shutdown

  • Pet Insurance

  • Subsidized Parking

  • Commuter Reimbursement Program

  • Brand new facility in Kendall Square

    Please Note: In accordance with Affinivax’s duty to provide and maintain a safe workplace that is free of known hazards, we have adopted a COVID-19 vaccine policy to protect the health of our employees and their families, our visitors, and the community at large from COVID-19. This policy requires all employees, contractors, and temporary workers, to (1) obtain an approved vaccination and provide proof of vaccination or (2) request an accommodation for a medical or religious exemption. Our policy is based on guidance from the Centers for Disease Control (CDC) and Prevention.

    Affinivax is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, disability, genetic information, status as a veteran or as a member of the military or status in any group protected by applicable federal or state laws.

    Agencies: All resumes submitted by search firms/employment agencies to any employee at Affinivax via email, the internet, or in any form and/or method will be deemed the sole property of Affinivax, unless such search firms/employment agencies were engaged by Affinivax for this position and a valid agreement with Affinivax is in place. In the event a candidate who was submitted outside of the Affinivax agency engagement process is hired, no fee or payment of any kind will be paid

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