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Process Architect

G-CON MANUFACTURING, INC.

Process Architect

Boston, MA +7 locations
Full Time
Paid
  • Responsibilities

    PROGRAM DESCRIPTION: This position is responsible for developing  standardized and configurable cleanroom infrastructure designs and  facility turnkey solutions for various process applications. The role requires the design and integration of entire biopharmaceutical manufacturing processes into G-CON’s cleanroom infrastructure and/or this infrastructure into a facility concept. Ultimately, the position will have created multiple turnkey facility design catalogues, which can utilized by the customer as templates to design and construct a manufacturing site.

    Supervisory Responsibilities: May supervise professional and/or support personnel

    ESSENTIAL JOB FUNCTIONS:

    Essential job functions represent the fundamental job duties and accountabilities of the employment position that the individual holding the position must be capable of performing. Persons with disabilities can perform these with or without reasonable accommodations. The Vice President or his/her designee may assign other duties limited to those consistent with the applicable scope of the appropriate professional job function.

    DESIGN TURNKEY FACILITIES OR CLEANROOM INFRASTRUCTURES FOR VARIOUS APPLICATIONS AND VOLUMES - 60%

    • Designs and plans standardized turnkey facility templates for various applications integrating cleanroom POD infrastructures into the facilities

    • Assures the different designs all meet the global regulatory standards and are CGMP compliant

    • The turnkey facilities would be fully designed with cleanroom infrastructures, support areas, warehousing, utilities, laboratories etc.

    • The turnkey facilities would consider all flows (material, personnel, waste, intermediates etc.)

    • The designs would allow for high accuracy budgetary pricing for the facility and delivery time  

    • The designs would be incorporated into different application oriented turnkey facility catalogues (cell therapy, gene therapy, viral vector, monoclonal antibodies, vaccines)

    SUPPORT CUSTOMERS WHO USE THE FACILITY CATALOGUE - 20% 

    • All the designs may require to be assissted by the process architect when customers have either specific questions or require to configure the turnkey solution

    • Presents turnkey solutions to the customer, so the customer can compare the different options

    • Supports client facility programming efforts

    TRAINS AND SUPPORTS SALES AND DESIGN CONSULTANTS - 10% 

    • Trains sales team on the facility designs and templates and shows the beenfits of the turnkey designs 

    • Creates a benefit catalogue for the turnkey solutions as a sales tool

    COLLABORATES WITH A&E FIRMS ON DESIGNS AND DESIGN PHASES - 10% 

    • Works in close collaboration with A&E firms, when tasked to implement G-CON’s turnkey design or work with them to create new turnkey designs

    • Trains A&E personnel on G-CON’s turnkey solutions

    • Answer any enquiries by A&Es about our turnkey solutions

    Position Specifications

    QUALIFICATION REQUIREMENTS:

    To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

    EDUCATION AND/OR EXPERIENCE:

    Master’s Degree equivalent year of experience: Process architect, facility architect, process designed, bio engineering or other related discipline

    Minimum of 10 years’: Biopharmaceutical work experience, especially design and engineering of related facilities, areas or processes

    Advanced Knowledge in cGMP, qualification or process validation requirements 

    Advanced Knowledge in cleanroom and/or controlled area designs and specifications

    Advanced Knowledge in facility lay-out and regulatory requirements for pharmaceutical and biotech products

    Advanced Knowledge in project management and related coordination of different functions

    Advanced Knowledge in design transfer to manufacturing

    Advanced Skills and knowledge in using computer-aided design systems (CAD).  

    Advanced Skill in report writing, articulation and correspondence with customers

    Advanced Skill in basic computer functions such as word processors, spreadsheets, and internet usage

    LANGUAGE ABILITIES:

    Ability to read and comprehend instructions, correspondence, memos, and work place policies. Ability to analyze, interpret general business periodicals, procedures and governmental regulations. Ability to analyze and interpret technical research journals.  Ability to write professional correspondences.  Ability to present information in small group and large group situations to customer, strategic business partners, the general public, and other employees.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the community. Ability to effectively present information to administrators, top management, public groups, community, and Board of Directors.

    MATHEMATICAL ABILITIES:

    Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Ability to compute rate, ratio, and percent and design and interpret charts and graphs to communicate business issues. Ability to work with mathematical concepts such as probability and statistical inferences to engineering and business issues.

    REASONING ABILITIES:

    Ability to carry out detailed written and/or verbal instructions. Ability to solve practical problems and deal with a variety of variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form to carry out business objectives. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

    TEMPERAMENT:

    Customer focus and action-oriented. Approachable and team oriented. Reliable performance under little structure. Flexibility and coping with change. Multitasking. Ability to maintain composure in a stressful environment. Freedom to work from supervision. 

    OTHER ABILITIES:

    • Ability to make decisions and recommendations

    • Ability to demonstrate professionalism with personnel and management

    • Collaborative team player

    • Ability to gather, organize and analyze information skillfully

    • Ability to lead effectively

    • Must be able to communicate effectively through oral and written communication

  • Locations
    San Francisco, CA • Chicago, IL • Boston, MA • Kansas City, MO • Dallas, TX • Houston, TX • Austin, TX • Seattle, WA