Associate Director/Principal, Automation Technology Engineer
Company: Affinivax Inc.
Location: Cambridge
Posted on: June 22, 2022
Job Description:
About AffinivaxAffinivax 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 accountsWho 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 systemsWhat 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 SquarePlease NoteIn 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.AgenciesAll
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
Keywords: Affinivax Inc., Cambridge , Associate Director/Principal, Automation Technology Engineer, Executive , Cambridge, Massachusetts
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