Process Automation Engineer – Pharmaceutical

MMR CONSULTING; Augusta (GA); On-site; USD 110,000 - 160,000; Full time

Job summary

MMR Consulting is seeking a Process Automation engineer to lead design, project execution and commissioning of process systems in the biopharmaceutical industry. The role requires leadership to mentor junior engineers and coordinate with equipment vendors and contractors.

Candidates should have extensive experience with DCS/SCADA/Historians, preferably with Emerson DeltaV, and be able to review electrical drawings, PLC/DCS code, and qualification protocols while collaborating across disciplines.

Qualifications

• Excellent written and spoken English is required.
• Knowledge of GMP requirements for pharma/biotech facilities.

Responsibilities

• Provide technical guidance into the design, project management, commissioning and start-up of automation systems.
• Support project execution from feasibility through handover including all design and procurement stages.
• Lead/mentor junior engineers and coordinate with vendors and contractors.
• Review and prepare URS/FRS, IQ/OQ, FAT/SAT activities and commissioning protocols.

Skills

Leadership

Mentorship

Project coordination

English communication

Education

Engineering degree (Electrical / Controls)

Tools

Emerson DeltaV

AutoCAD

PLC programming

SCADA/Historians

Job description

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries. Its services include Engineering, Project Management, and Validation. MMR has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in the engineering and project management of equipment, systems and facilities for life sciences facilities. Some travel to client sites is expected.

This role is for a Process Automation engineer to work on the design, project execution and commissioning of process systems in the biopharmaceutical industry. The ideal candidate should possess leadership skills to lead/mentor junior engineers, equipment vendors, contractors.

Responsibilities

• Provide technical guidance into the design, project management, commissioning and start-up of automation systems, for upgrades, renovations and expansions of client facilities and processes.
• Support project execution from Feasibility through to project completion/handover, including all project stages such as:
  • Feasibility
  • Concept Design, Basic Design, Detailed Design
  • Procurement
  • Construction
  • Project Monitoring/Governance
  • Commissioning & Qualification
• The ideal candidate has experience in Distributed Control Systems (DCS) such as Emerson DeltaV, and preferably has experience in SCADA/Historians, specifically within process controls in biopharmaceutical industry.
• Prepare/perform/review electrical drawings, such as Panel Drawings, wiring diagrams, single line drawings.
• Perform programming / configuration on PLCs, DCS or SCADA/Historians
• Review programming of equipment vendors and other automation firms
• Perform automation / electrical troubleshooting on electrical panels and control systems
• Familiarity with ISA 88 / 95 Standards for automation.
• Facilitate work efforts with other disciplines such as Process Engineering, Mechanical, Validation, and client’s internal stakeholders.
• Prepare/review User Requirements Specifications (URS), Functional Requirements Specifications (FRS), SDS, DDS, Valve & Alarm Matrices.
• Provide input into Commissioning (FAT, SAT) and Qualification Protocols (IQOQ), as well as support execution of Commissioning & Qualification.
• Experience with, and knowledge of some of the typical Biotechnology processes & peripheral systems is required; Upstream Biotech Processes (Fermentation, Bioreactors, Centrifugation, Thawing), Downstream / Purification Biotech Processes (chromatography, TFF, DF, NF-MF), Fill & Finish equipment, Media Preparation, CIP/SIP systems, Buffer Preparation, clean utilities (PW, WFI, CS, PS)
• Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable
• Visit construction and installation sites.
• Supervise contractors during critical installations of process equipment and associated utilities.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, Change Controls.
• Detailed knowledge of GAMP and its application to large and small scale systems.
• Detailed knowledge of data integrity requirements.
  • Years of experience: Minimum 5+ years of pharma (8+ years is preferred) process automation engineering experience, with at least 3 years (5+ years is preferred) of process controls experience with DCS / SCADA / Historians with upstream or downstream bioprocesses.
• Ability to read electrical drawings, PLC code, DCS code.
• Ability to perform programming/configuration of Emerson DeltaV DCS.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Basic knowledge of AutoCAD is an asset.
• Engineering degree, preferably in Electrical, Electromechanical, Controls, Chemical, Mechanical Engineering or a related discipline.