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Peli BioThermal is a global leader in the design and manufacture of single use and reusable temperature-controlled packaging solutions for the highly regulated pharmaceutical, biotech and clinical trials industries. The Global Services division of Peli BioThermal enhances the customer offering with the Credo on Demand, Credo on Reserve and Customer Owned Inventory programs.

The Peli BioThermal Engineering Department develop and qualify the product portfolio. The Global Services Process and Engineering Team are responsible for the specification, deployment, maintenance and qualification of the technical infrastructure, the operational processes employed in the service network and the technical studies required to be able to quantify and manage the capabilities and capacities of the operations.

Peli BioThermal is a great place to work and offers employees the opportunity to flourish and excel in a high-growth, fast-paced, creative, and exciting environment!

Primary Duties and Responsibilites

• Works closely with PBT Engineering to transfer the products and processes to the service network.

• Develop and implement a Process and Engineering Lifecycle that encompasses industry best practice, reflects Corporate Policy and Strategic Objectives and supports Continuous Improvement

• Establish and manage a Continual Professional Development program to ensure the team members are current with the latest industry GxP and Regulatory Developments.

• Company systems – Lead the continued development of ProEnvision and support the SAP implementation to ensure that Service Programs, Operations and associated products and materials are set up in SAP and are extended to the Service Center network

• Leads and manages a diverse Engineering Team encompassing:

• Technical Infrastructure Specification

• Development of Work Instructions

• Designing and implementing technical studies e.g. Time in Motion

• Supporting associated IT developments

• Systems for CAD and data analysis

• Technical support for products and product conditioning procedures

• Process Testing and Qualification to ISTA and ISO standards

• Technical drawings and documentation generation and control

• Industry and Regulatory Body compliance and liaison

• Process improvement and validation activities

• Technical and Quality Approval Process

• Adheres to Change Control processes (ECO) and development thereof.

• Adheres to Quality Procedures and development thereof for the team.

• Supporting the extension of the existing Environmental Sustainability Studies from Product in isolation to encompass Product within a Service Program

• Develops and manages Engineering resources to achieve business objectives.

• Inspires engineering teams to deliver excellence in creative design, qualification and technical support services.

• Maintains close connections to industry bodies.

• Provides technical expertise and support for Service Centers.

• Project Manager and leader for complex technical projects, organizational development and continuous improvement projects involving engineering and other cross functional team members.

• Leads, directs and supports customized service offerings

• Follows company policies and practices as outlined in the Employee Handbook, AWAIR and/or applicable employment agreement. Follows safety guidelines and procedures in accordance to the job.

• Performs additional duties as assigned.

• Prepare and manages department budget and finances

• Global Services Management Team Reporting, Strategy Development, Planning, Coordinating Activities

• Establish a dashboard of KPI’s and create the mechanism that enable KPI’s to be tracked and reported.

Qualifications and Experience

• Education: BS in Engineering, Mechanical, Chemical, Packaging or a similar discipline

• Previous experience in an engineering or design role utilizing CAD would be highly desirable.

Preferred Qualifications

• Master’s Degree, MBA or PMI/PMP certification

• Previous experience in an engineering or design role utilizing CAD preferred.

• Knowledge of Six Sigma, Lean Design, Problem Solving techniques and FMEA are desired.

  Competencies

  General

• Actively supports and complies with Pelican’s objectives, guidelines and commitment to Quality and Safety, with an emphasis on continual improvement.

• Must be able to interact effectively and cooperatively with employees at all levels.

• Must have the ability to complete assignments within the timeframe specified by the Manager.

• Must be flexible regarding working hours. Must be able to work evenings and weekends, with or without advanced notice.

• Ensures that staff is contributing at maximum potential through rigorous hiring practices and an emphasis on training and development initiatives, including coaching and counseling direct reports in their performance and professional development, with final authority for approving pay increases, hiring decisions and disciplinary actions.

• Emphasizes ethical leadership and decision-making to protect Pelican’s brand and reputation.

• Establishes challenging, productive, and achievable goals for direct reports; measure results by establishing checkpoints to track progress.

• Must be able to travel, nationally and internationally, as necessary and up to 50%

  Project /Practice Management

• Creates and executes project work plans and revises as appropriate to meet changing needs and requirements.

• Identifies resources needed and assigns individual responsibilities.

• Reviews operational aspects of projects.

• Effectively applies our methodology and enforces project standards.

• Minimizes our exposure and risk on project.

• Ensures project documents are complete, current, and stored appropriately.

• Leads proposal efforts including completing project scoping and LOE assessments.

• Understands basic revenue models, P/L, and cost-to-completion projections and makes decisions accordingly.

  Communication

• Holds regular status meetings with engineering and cross functional teams.

• Effectively communicates relevant project information to superiors.

• Delivers engaging, informative, well-organized presentations.

• Resolves and/or escalates issues in a timely fashion.

• Understands how to communicate difficult/sensitive information tactfully.

  Leadership

• Challenges others to develop as leaders while serving as a role model and mentor.

• Inspires coworkers to attain goals and pursue excellence.

• Identifies opportunities for improvement and makes constructive suggestions for change.

• Manages the process of innovative change effectively.

• Remains on the forefront of emerging industry practices.

  Teamwork

• Consistently acknowledges and appreciates each team member's contributions.

• Effectively utilizes each team member to his/her fullest potential.

• Motivates team to work together in the most efficient manner.

• Keeps track of lessons learned and shares those lessons with team members.

• Mitigates team conflict and communication problems.

  Physical Requirements and Working Conditions

• While performing the duties of this job, the employee will be frequently required to execute standard physical activities within the facility areas (i.e. stand, walk, sit, use hands/fingers).

• While performing the duties of this job, the employee will be occasionally required to execute non-standard physical activities within the facility areas (i.e. climb or balance, stoop, kneel, crouch).

• Ability to lift and/or move up to 10 pounds and occasionally lift and/or move up to 40 pounds.

• This position requires repetitive hand/wrist activities.

#pelibiothermal

Pelican Products, Inc. is an Equal Employment Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.