Responsibilities may include the following and other duties may be assigned. Leads or leverages cross functional teams to evaluate, develop and manage projects for new product development and ongoing lifecycle management of products, processes and therapies. Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management. Manages the development and implementation process of a company’s products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes. Reviews status of projects and budgets; manages schedules and prepares status reports. Monitors the project from initiation through delivery. Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients. Gathers requirements, works on requirements planning, requirements elicitation and requirements management to ensure they meet demands of project’s key stakeholders. Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills. DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Engineer or Specialist for equipment and process validation including IQ, OQ, TMV/MSA, PQ protocol generation and execution.
Resource will be hands-on with automation, tooling, and maintenance technicians to coordinate and follow-up on equipment troubleshooting , repairs or service required to assure that equipment validation is successful and for resolution of any deviation.
Good team-member, with communication and time management skills to keep-up with project timeline.
What are the top 3 things you are looking for in a candidates experience:
- experience in equipment validations protocol generation, execution and report
- good time management skills to comply with timeline
- good team member
Education Required: Engineering preferred, Science or technical background
Years’ Experience Required: 2 years at least in validation engineering/specialist
What We Do
MENTOR Technical Group is a team of highly educated, superior trained, and dedicated professionals with expertise and experience to provide a complete portfolio of technical support and solutions for the FDA-regulated industry. MENTOR Technical Group delivers solutions with a flexible cost-effective approach to meet your company’s needs. Our purpose is to help you bridge the gap between your business strategies and results, by balancing three major aspects: People, Regulatory and Compliance, and Technology.
MENTOR Technical Group’s objective is to deliver reliable tailored solutions—from consultation to becoming part of your staff. This proximity helps us develop customized frameworks to help you unlock the hidden value in your plants, facilities, equipment, and staff, while optimally integrating resources, regulations, and technology.
MENTOR Technical Group’s commitment begins by getting involved from the conceptual phase up to the implementation phase of your projects. Our management staff has unparalleled experience in both the operating and consulting industries. We have over 200 technical staff members, which allows for efficient project execution.
At MENTOR Technical Group, we deliver on our commitments—every time, on time. Our enthusiastic highly skilled workforce consistently meets or exceeds client expectations. We don’t just perform for our clients; we work with integrity. Our professional staff takes pride in their work and acts with a sense of ownership.
