Technical Lead

Fishers, IN, United States

ViTalent , a leader in talent development and talent acquisition strategies focused on life sciences, is pleased to present the following opportunity with a key industry partner.

We seek a Technical Lead to supervise the design, development and testing processes resulting in the successful transfer to production. Experience in regulated environments (FDA, GMP, Life Sciences) is preferred.

Our client, the Stevanato Group , is a 70+ year old international leader specializing in world-class systems, processes, and services for the Pharmaceutical and Healthcare industries. With global operations including 14 production and commercial sites, the company is poised for continued growth in the sustainable life sciences sector.

The organization has committed to an even stronger US presence located in Fishers, Indiana. A new, world-class facility is underway, so this is an exciting time to join an innovative and forward-thinking organization.

The candidate selected for the role will enjoy a very competitive pay package and industry-leading benefits.

The Technical Lead is responsible for effectively and efficiently supervising the design, development and testing processes resulting in the successful transfer to production. While collaborating with process technology team, the Technical Lead will act as a reference within the relevant area, identifying feasible solutions and providing technical guidance and expertise to meet priorities, deadlines, budget and quality.

Essential Job Functions and Responsibilities

TECHNICAL AREA PROCESS MANAGEMENT

Provides Leadership with prompt and timely analysis and recommendations on critical points, ensuring processes standardization across the relevant technical area assigned.

Leads the processes related to structural analysis, tolerance and dimensions calculation in order to build the design and other associated activities in line with the internal and external stakeholders' requirements and in accordance with company procedures, regulatory requirements and other applicable standards.

Acts as reference person, supervising processes and resources within the relevant area of expertise for both existing and innovative solutions as well as equipment upgrading, translating the technical specifications for the relevant area assigned, working alongside product and system owner and the other technical area teams.

Enables the successful transfer of designing phases to Production team, alongside with process technology team and the other functions involved, overseeing the properly testing and parametrization activities and according to the technical specifications.

Builds and maintains bills of materials for the relevant area, interacting with the other functions involved such as Procurement team, production team or with supplier in case of further information on technical specifications related to materials and components.

Oversees the follow-up process, revising designs according to customer feedback and other data, identifying areas of improvement, fostering continuous improvement approach and taking care of the consequent changes, in accordance with the Leader above.

PROJECT MANAGEMENT

Supervises the project assigned, from requirements collections, feasibility, design, testing and the relevant resources, liaising with Project Team, working in line with project plan and the relevant methodology. Solves critical issues, implementing promptly the preventive and corrective actions approved in order to achieve the expected outcomes.

GUIDELINES, PROCEDURES AND DOCUMENTATION MANAGEMENT

Establishes and cascades guidelines and policies in order to guide the relevant operational processes according to the leader above and deploying the appropriate implementation.

Maintains the properly documents management execution, across the relevant technical area assigned, keeping activities running into the best-in-class efficiency and effectively way, in order to ensure all the relevant documentation required, in accordance with the applicable standards, regulations and guidelines.

REPORTING AND MONITORING

Monitors promptly performances and KPI's, identifies improvement and critical areas, sets up contingency plans, in accordance with the strategy, as well as inputs provided by the Leader above in order foster sustainable growth, managing risk appropriately.

PEOPLE MANAGEMENT

Supervises the team assigned and drives high level of commitment on results achievement, engages the team in acting according with company values and principle.

RELATIONSHIP MANAGEMENT

Deals with the external stakeholders related to development projects, with the aim of promote the SG business areas expertise as well as provides the team with guidance, standards and trends with the aim of ensuring the compliance of the company portfolio and driving the future product developments with SG4D approach.

Regularly, proactively and effectively interacts and communicates with both internal leaders and team and relevant stakeholders, ensuring that they are constantly aligned on key activities, targets and achievements of the

Other Requirements of Job

SAFETY

Responsible to ensure team complies with all safety requirements promoting a Safety-First culture striving for an injury free workplace.

PPE such as safety glasses, safety shoes, gloves, and gowning are required in designated areas.

Tasks may include standing, walking, bending, lifting up to 50 pounds, and sitting.

Education, Experience, Skills & Technical Competences

EDUCATION AND EXPERIENCE 3 years of experiences in Technical Department or Engineering R&D in roles of responsibility within medical device, pharma industries.

Engineering or Technical Master Degree, or equivalent experience/exposure

SKILLS Verbal and written communication, including active listening, for determining and discussing building needs and communicating these to contractors, suppliers, and the occupants.

Leadership and Accountability

Customer service for occupant and stakeholder satisfaction

Analytical thinking and problem-solving

Business management, including scheduling, strategic planning and administration.

End results mindset

Resource management (coaching, feedback, team management, etc.).

TECHNICAL COMPETENCIES Computer literacy and confidence using Microsoft Office, accounting and electronic management programs.

Production knowledge: process, features, techniques, tools and applications.

Knowledge of Technologies, Product/Packaging and Production: process, features techniques

Knowledge of Design Control and Design Manufacturing and Assembly: process, features, techniques

Knowledge of applicable standards such as ISO GMPs, CGMPs, FDA etc.

Knowledge of safety standards (HSE): methodologies, techniques, tools and applications Basis of Risk Management: methodologies, techniques, tools and applications

Knowledge of Quality Management System: process, features techniques Project Management: methodologies, techniques, tools and applications

Job Type

Full-time

Benefits 401(k)

401(k) matching

Dental insurance

Employee assistance program

Employee discount

Flexible schedule

Flexible spending account

Health insurance

Health savings account

Life insurance

Paid time off

Parental leave

Tuition reimbursement

Vision insurance

Schedule Day shift

Monday to Friday

Work Location

In person

If you are qualified, please submit your resume for immediate consideration. Sponsorship is not available for the role, so please do not apply if you are not authorized to work in the US without sponsorship.

Please visit www.ViTalent.com for additional information. Thank you.