Engineering Consultant

Location: Greater Boston Area

Job Description

Azzur Group is seeking mid to senior level Engineering Consultants to join our professional service team! Engineering Consultants are Azzur employees who work directly at our client sites in the New England region delivering projects to our valued clients. Our engineering areas of expertise lie in Validation, Commissioning & Qualification, Calibration, Facilities Engineering & Process Engineering. As an Engineering Consultant, you could be assigned to any expertise area, a great way to gain exposure across the Pharmaceutical and Biotech industries!

If you are a dynamic, flexible, go-getter, we want to hear from you!



Essential Duties and Responsibilities

Azzur Responsibilities:

  • Assists Azzur Group in meeting sales and business goals by providing outstanding services to our clients.
  • Represents Azzur at client sites; is punctual and reliable.
  • Provides recommendations for improvement to client as needed or observed.
  • Reports weekly project status to Director of Engineering.
  • Assist/mentors junior engineers on projects as needed.
  • Attends company quarterly meetings, bi-annual outings, and other planned events/meetings.
  • Complies with all Azzur agreements, policies, and procedures.

Typical Project Responsibilities:

  • Generates and executes life cycle documentation (FAT, SAT, IQ, OQ, PQ) for any of the following areas: cleaning, shipping, equipment, systems, utilities and processes for qualification/verification and/or re-qualification/re-verification.
  • Writes and executes protocols, resolves deviations/ discrepancies, reviews and analyzes study data, writes summary reports.
  • Initiates and performs investigations to close out deviations. Ensures corrective actions are resolved in a timely manner.
  • Reviews, advises on and contributes to change control documents. Provides sound validation/verification assessments.
  • Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
  • Writes reports to summarize validation/verification /commissioning and/or revalidation/verification/ commissioning activities.
  • Performs P&ID Walkdowns.
  • Performs Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.
  • Supports the resolution of regulatory observations or manufacturing site issues.
  • Writes procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments.
  • May assist in providing training.
  • Develops Validation Plans for small to medium size validation projects, qualification and validation of equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes.
  • Provides assistance with project management for commissioning, qualification of new engineering systems.
  • Carries out duties in compliance with all local, state, and federal regulations and guidelines including the FDA, EPA, and OSHA.
  • Complies with all client site policies and procedures.
  • Successfully completes job-training requirements.
  • Individuals must represent AZNE at client sites and interact confidently with clients, contractors, management and peers.


Qualifications

  • BS degree in Engineering, Science, or equivalent technical degree.
  • 4-8 years experience in validation services in a regulated, manufacturing environment within the
    biotechnology or pharmaceutical industry.
  • Excellent written and verbal communication skills; excellent technical writing skills.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Ability/flexibility to work on more than one project.
  • Ability to manage small to medium size projects.
  • Strong Project Management skills.
  • Strong Working knowledge of FDA and cGMP regulations and documentation practices.
  • Experience with temperature mapping.
  • Experience with many aspects of validation is expected.
  • Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.
  • Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical or schedule form. Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams.
  • Ability to define problems, collect data, establish facts and draw valid conclusions.
  • Highly motivated and organized, solutions oriented leader.
  • Ensures activities are efficient, optimized and client-centric.
  • Proficient in Microsoft Word, Project, Excel, PowerPoint, and Google Suite.
  • Ability to travel to any New England site including New York for long term projects.