Automation & CSV Manager

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

We are looking for an Automation Manager to be responsible for project leadership and daily support of our client's Automation Systems. This collection of systems spans GMP and non-GMP systems, design, build, commission, validation and possible lifecycle support. The role will require effective collaboration and support to functional areas such as Manufacturing, Quality, Process Engineering, Validation, and other applicable stakeholders. Must have experience working in the Life Sciences (Medical Device or Biopharmaceuticals).

The candidate should be willing to travel to client projects. This role could be up to 60% travel. Dependent on project, 100% onsite client support may be required. VTI Life Sciences will support the immigration status of potential candidates if the candidates meet job description requirements.

Summary of Key Responsibilities 

• Lead the planning and execution of Automation systems being implemented at the client facility.
• Applies advanced Automation engineering principles to the design and implementation of system modifications, experiments and/or capital projects; develops, organizes, analyzes, and presents interpretation of results for operational issues or Automation engineering projects of significant scope and complexity.
• Automation Project Leader for site projects including expansions and upgrade activities, providing day to day technical leadership to the project team in all project phases (design, delivery, startup, commissioning, validation, and operational support). 
• Manages and/or applies extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems such as facilities or processes. 
• Provide Subject Matter Expertise for capital projects, including automation system design, control system hardware, equipment design, control panel design, and instrumentation start-up and troubleshooting.
• Develop company automation capabilities, including development of technical standards, guidelines, and procedures in accordance with industry best practices for executing large capital projects. 
• Support manufacturing operations, including troubleshooting of operational issues in manufacturing, maintenance, validation, or capital projects.
• Promote a culture of safe and compliant design and operation. 
• Serve as technical process automation leader for large capital projects, interfacing with stakeholders and external consultants / contractors. 
• Review and critique process and automation system designs and support project lifecycle activities in alignment with various manufacturing systems. 
• Manage all aspects of automation system design and integration, including specification development, integration, validation, and technology transfers. 
• Lead efforts with manufacturing, process development, facilities, QA, and other stakeholders in developing user requirements and recommendations for system implementations and modifications. 
• Support the writing and execution of FATs, SATs, Design, Installation, Operational and Performance Qualification Protocols for Automated Systems.
• Provide oversight of Automation system service providers, contract resources and Instrument/Electrical technicians ensuring safe, compliant maintenance and project execution. 
• Lead Automation issue identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA) and Process Failure Mode and Effect Analysis (PFMEA).
• Leverage technical and business expertise to identify potential clients that match the strategic needs of the business.
• For profitable and sustainable financial performance, safety, compliance programs, and contractual and technical management.
• Leading project teams you’ll provide primary client relationships with client management and technical personnel and report regularly as to client confidence, satisfaction, and/or problems.
• Build and nurture relationships with potential clients via conferences and professional organizations.
• Evaluate inbound opportunities for strategic fit and execute where appropriate.
• Support recruiting team with resource needs.
• Organize teams for due diligence and execute assigned activities.
• Frame and quantify business potential and investment risk for growth opportunities, e.g., new market entry or footprint expansion.
• Exhibit strong teamwork within and beyond the team to drive functional success.
• Engage, mentor and challenge team members.
• Maintain established project cost levels to ensure profitability ratios and work to actively increase margins; and develop new work and/or expand existing work and report on all competitive contract services sales efforts, advise marketing personnel of these efforts, and prepare reports and presentations as required.

Qualifications 

• Requires a Bachelor's degree in Electrical or Chemical Engineering or related technical field 
• Must have experience working in the Life Sciences (Medical Device/Biopharma)
• 6+ years of relevant work experience – including design, build, test and ongoing operations support 
• Manufacturing experience, including experience managing automation projects and leading automation system design, including 24x7 manufacturing operational support 
• Strong understanding of GMPs, Computerized Systems Validation (CSV) and good engineering practice (GEP), including ISA S88/S95, ISO 13485, GAMP, ASTM E2500, ISPE guidance, 21 CFR Part 11, Annex 11, Data Integrity, etc. 
• Preferred experience in the implementation of automation equipment and systems such as vision, automated assembly, Rockwell, Siemens, Ignition, Honeywell, Delta V, etc.

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org