Department: Azzur Consulting LLC
The Automation Engineer is responsible for day-to-day operations support activities including problem solving, develop short and long term solutions for automation problems, validating computer equipment, maintaining current systems in a Good Manufacturing Practice (GMP) state and creating/maintaining standard operating procedures for the systems.
- Support validation as the Subject Matter Expert to ensure that appropriate regulations (e.g. 21 CFR Part 11 and cGMP) are addressed in validation in a development phase and level.
- Interface with IT to ensure GMP compliant integration with Corporate IT infrastructure.
- Prepare, assist, and participate in system, specification development, and design.
- Provide support on a daily basis on Building Management Systems and Process Control Systems.
- Coding, programming, and configuration for continuous and batch controls.
- Responsible for DeltaV Batch recipe configuration, phases, EMs, CMs.
- Develop procedures to transfer technologies, recipes, parameters from process development to commercial manufacturing.
- Responsible for the DeltaV
- Responsible for the OSI Soft PI Historian configuration and maintenance.
- Maintain Functional Specifications, Database Design Specifications and Hardware Design Specifications for automation systems.
- Develop and maintain Automation Standard Operating Procedures and training for Automation Systems.
- Perform Engineering Test Plans for Automation.
- Support, configuration and maintain automation reporting systems like Infobatch.
- Execute Software Test Specification.
- Maintain backups of automation code.
- Provide engineering and technical review of new equipment purchases, including design review, FAT and SAT.
- Perform all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulations and industry codes.
- Act as SPOC on site for technical transfer.
- Perform technical feasibility assessment for supply point decision in close collaboration with other stakeholders. Determine scope / design of technical batches for transfer.
- Provide input into overall project strategy and plans including timelines.
- Initiate local change control in system on site and ensure approval and closure.
- Establish site project plan, elaborate scientifically sound technical strategies with project team, develop contingency plans, identify hurdles and propose solutions. Assess and plan site resource needs and get management approval for the overall project costs (e.g. FTEs, batch costs, investments and external costs), strategies, and timelines.
- Form and lead site project team - set priorities for project and project team meetings, coordinate project team activities, ensure that Novartis guidelines and HSE and GMP guidelines are met.
- Ensure that project tracking documentation/tools are up-dated according to plan.
- Ensure timely availability of technical documentation according to Novartis guidelines. Write Manufacturing Process Transfer Documents (protocol, report).
- Review key documents and coordinate input for relevant registration documents for accuracy and completeness (as appropriate).
Required Skills & Abilities
- Knowledge in Manufacturing Enterprise System including Weight and Dispense and EBR.
- Experience with Process Control System, SCADA design, implementation and operation of systems.
- Develop new code for continuous control and batch control.
- BMS, SCADA and DCS design, commissioning and validation in GMP facility.
- Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA.
- Computer knowledge of 21 CFR Part 11.
- Understand automation protocols like: HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC and Modbus TCP/IP.
- Experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, APOGEE, etc.
- Reliable, self-motivated individual with positive attitude; team-oriented with the ability to work with staff covering a variety of roles.
- Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities.
- Strong written, verbal and interpersonal communications skills and a strong attention to detail. Must be able to develop, draft and correct preventative maintenance procedures for technical equipment.
- Must be able to work effectively and efficiently with minimal supervision in a schedule-driven, changing work environment.
- Working knowledge of MS Office products (Word, Excel, Outlook, and Power Point).
- Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.
- Liaise with global project manager, giving site (CMC team for development transfers) and site functions. Ensure knowledge transfer from giving site to receiving site including to operators.
- Ensure transfer timelines align with overall site project plans.
- Contribute to inspection (Pre-Approval Inspection PAI) readiness.
- Ensure site readiness for campaign start-up.
- Bachelor’s Degree preferably in Chemical, Electrical, Mechanical Engineering or closely related field with 3 (3) to five (5) years of relevant automation engineering experience preferably in the biotechnology /pharmaceutical industry;
- Experience with critical utility and non-GMP utility systems a plus.
Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
- Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry.
- Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
- Understands worldwide regulations and phase appropriate applications.
- Draws insights from projects and supplemental research to help drive new and existing growth.
- Ensures activities are efficient, optimized, and client-centric.
- Highly motivated and organized, solutions oriented leader.
- Curious and adaptable - has the ability to transform knowledge into actionable activities.
- Able to produce results in a fast paced, collaborative environment.
Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM.
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Do What You Love
At Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals. We take crucial steps to ensure that each employee is fulfilled both in and out of the office.
In addition to our purpose, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 5 core values; Integrity, Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun.
It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.
We are an equal opportunity employer and promote diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.
If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent and fun company culture are something you are looking for in your next role, Azzur is the place for you.