Maja Smilevska

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Principle Solutions Consultant

Ref #: ID: 32087
Maja Smilevska 15/12/2021
Location: United States Not Disclosed United States
Salary: TBC £
OTE: Plus bonus and profit share
Type: Permanent
Seniority: Mid/Senior Level
Specialisms: MES, Pas-x, Syncade, Pharmasuite, Pharmaceutical, Batch
Date: 15/12/2021
Principle Solutions Consultant

Our client are an industry-leading provider of world-class MES solutions, who are committed to improving the effectiveness, competitiveness, and compliance of regulated manufacturers in the health sciences industries. Based in the USA, they have over 100 systems and more than 25,000 users distributed across 20 countries – making them one of the most widely used MES offerings around the globe.

What the position is

We are seeking a highly qualified Principal Solutions Consultant to lead our customer implementation projects within our Professional Services organization. This position is a senior position within the organization, responsible for customer satisfaction and project success.

What you will do

As a member of our project team, you will help lead successful customer implementation projects by applying your product knowledge and project implementation experience. Your span of responsibility for this position can include multiple domestic and international projects.

Specific Roles and Responsibilities:

  • Lead and coordinate all project activities in collaboration with the Project Manager. You may assume the role of Project Manager on smaller projects. Report progress and issues to Customer project managers in a regular and timely manner.
  • Lead workshops to analyze user requirements and define functional requirements for MES solutions through client interviews and documentation analysis.
  • Lead the discussions with the customer to evaluate requirements and business processes, review functional and technical designs and develop solutions to satisfy requirements. Author design documentation which describes the to-be solution and its fit into the solution landscape.
  • Understand the complexities and requirements of customer business applications such as ERP, LIMS and DCS systems. Design interfaces between their MES products and customer business systems. Utilize business application integration products to interface between systems.
  • Understand and decompose customer’s manufacturing processes and configure them in their MES products through electronic recipes and work instructions.
  • Lead and coordinate the definition, collection, configuration and modeling of customer data for the products. Determine the appropriate methods for data loading into the systems. Provide guidance and expertise to and Customer project teams with understanding data requirements and data reporting.
  • Coordinate activities of the technical specialists for product installation (Installation Verification Manual) and interfaces including design, implementation, testing and documentation.
  • Understand and support customer system validation requirements and industry regulations (e.g. FDA regulations, GAMP etc.) for pharmaceutical and regulated industries. Assist in authoring validation and testing documentation to support customer’s validation efforts.
  • Develop and maintain detailed functional knowledge of the products. Develop a practical and basic working knowledge of relational databases, barcode label software, reporting software and other software products as required.
  • Lead in the creation of project plans consisting of deliverables, tasks, work packages, levels of effort, dependencies, and schedules. Liaise between customer project teams and management, and internal project team and management.
  • Participate in quoting and estimating of project scope to ensure successful project execution.
  • Develop customer relationships and anticipate customer needs with a priority on customer satisfaction.
  • Educate customers on project methodologies with a goal towards enhancing the customer’s standards.
  • Ability to review sales proposals and engineering studies to ensure accurate estimates for identified scope of work.
  • Act and represent them as an industry-wide expert in MES and serve as a technical subject matter expert.
  • Lead customer facing technical communications.
  • Mentor internal Solutions Consultants.

Who you are (the soft skills)

As our ideal candidate, you have

  • Commitment to customer satisfaction: you are focused on customer goals and objectives and helping them attain them.
  • Strong verbal communication skills: you speak clearly and persuasively in positive or negative situations, you actively listen and ask for clarification, you respond well to questions, and you are comfortable presenting to a group
  • Strong written communication skills: you write clearly and informatively, you can vary your writing style to meet needs, and you are able to present numerical data effectively
  • Strong leadership skills: you lead through a clear set of values, you champion and facilitate change, you inspire others, you demonstrate and encourage adaptability, and you operate best through an inclusive leadership style
  • Strong analytical skills: you can synthesize complex and diverse information, you gather and analyze information skillfully, and you are able to apply intuition and experience to complement the data
  • Strong problem-solving skills: you identify and resolve problems in a timely manner, your decision-making process is data driven, you can develop alternative solutions, you work well in group problem solving situations, and you use reason even when dealing with emotional topics
  • Strong planning skills: you can prioritize and plan work activities, you can organize and schedule other people and their tasks
  • Strong character: you demonstrate unquestionable integrity in every aspect of your work and interactions with others, you consistently model the behaviors and values established by the company, and you respect diversity of perspective in all interactions
  • A highly collaborative mindset: you build and maintain partnerships with clients and people at all levels of the company, you actively contribute to team and company success, you maintain flexibility and react to change appropriately, and you communicate and share information with candor that builds trust and enhances relationships
  • Strong understanding of ISA S95 and S88 standards and terminologies
  • Strong understanding of FDA validation requirements
  • Strong experience with multiple plant floor/Manufacturing Execution Systems (MES) solutions (e.g. Syncade, Rockwell, ProPack Data, Werum PAS-X) and integration with other Level 2, 3 and 4 systems

Your experience

  • BS or MS degree in a technical field (preferably engineering or computer science)
  • 15+ years of work experience, with 10+ years of experience with MES applications in the Pharmaceutical, Biotech or Medical Device industries.
  • Knowledge of Good Manufacturing Practices (GMP’s), Food and Drug Administration (FDA) Guidelines and Good Automated Manufacturing Practice (GAMP)
  • Knowledge of relational databases and SQL
  • Programming experience a plus

Willing to travel overnight and internationally up to 40% of normal work quarter (typically < 25% travel). Remote candidates will be considered.

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