AUTOMATION VALIDATION SPECIALIST

Pharmaceutical - AUTOMATION VALIDATION ENGINEER

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 project management, commissioning and qualification, of equipment, systems and facilities. This role is based out of the Greater Toronto, ON area. Some travel within the GTA is expected.
This role is for an Automation Validation Engineer role to work on the commissioning, qualification, startup of Automation systems in the pharma/biotech industry, such as Process Controls and Building Automation. The ideal candidate should possess leadership skills to lead/mentor junior engineers.
Previous Pharmaceutical/Biotech experience is mandatory for this role.

Responsibilities
• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
• Performed gap analysis procedures and detailed data reviews to optimize implementation.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of either Process Controls (i.e. DCS, PLCs, SCADA/Historians) or Building Automation Systems (i.e. Siemens Insight / Desigo, JCI Metasys) is required
• Tested, automated and whitelisted software to be used in secure environments
• Proficient in Siemens TIA Portal, PCS7 and wincc
• Experience in PAS-X Functional Configuration
• Expertise in python, R, tableau, Dot Net
• Has experience in implementing of serialization, track & trace for vaccine manufacturing companies
• Proficient cGMP, 21 CFR Part 11, GAMP, Data Integrity
• Exposure to ISA 88, ISA 95 guidelines
• Provide technical expertise and leadership to design process and motion control automation development as per standard guideline like ISA- 88,95,99,101.
• Provide design support and programming for PLC's, motion control, vision applications, robotic systems and PC controlled equipment within good Engineering Practice.
• Monitor and evaluate safety practices and ensure compliance with legislation wherever relevant.
• Monitor and evaluate safety practices and ensure compliance with legislation wherever relevant.
• Experience in CD, BD and DD project phases and Involved in the end-to-end integration of green project
• Exposure to put the automation strategy, System architecture & TIC in CD phase, preparation/review of design document
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• 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 testing of system and equipment.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.
Qualifications
• Ability to lift 50 lbs.
• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 3+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 3+ years should include direct C&Q experience with either process automation or building automation systems in the pharma/biotech industry.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects.
• Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
• Knowledge of GAMP and Data Integrity requirements.
• Knowledge of the V-Model for Computer System Validation is required.
• Knowledge of ISA-88 and ISA-95 Standards is considered an asset.
• Experience with commissioning & qualification of either process control systems (i.e. PCS, SCADA, Historians) or building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) is considered an asset.
• Proficiency in PAS-X Functional Configuration, Siemens TIA Portal, PCS7 and wincc is required
• Experience in python, R, tableau, Dot Net software is required.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is considered an asset.
• Experience with preparation and execution of URS’s, DQ’s, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.
• 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.
• Engineering or Science diploma, preferably in Electronics and communication engineering, Mechanical, Electrical, Electromechanical, Chemical, Biochemical or a related discipline.
• Travel may be required on occasion.
• Ability to handle multiple projects and work in a fast paced environment.
• Strong multi-tasking skills

WHAT WE OFFER
• Full-time and permanent employment;
• Annual salary of $100,000 plus all work-related expenses would be shouldered by the company;
• Medical, Dental, Disability Insurance, WSIB;
• 40 hours per week with flexible work options (Work-from-home and in-person available)
LOCATION OF WORK
• 81 Zenway Blvd, Unit 3A, Vaughan, ON, L4H 0S5, Canada
HOW TO APPLY
• Please submit your CV and cover letter to mmrconsulting.hr@gmail.com