Carex Scientific's world-renowned partner in Madison, WI is currently seeking an innovative and industry-leading Director, Engineering to help assess, develop strategy and implement continuous best-in-class solutions that keep the company at the forefront of the biotech and life science industry. Individuals with strong process and automation engineering experience, as well as strength or exposure to packaging engineering, in the highly regulated biotechnology, pharmaceutical or similar life science industry that are looking to work on a breadth of projects from capital and equipment to vendor management will thrive in this role. If you're a serve-first leader that wants the leeway and ability to take your team and department where you best see fit and bring in resources to stay cutting-edge, this opportunity could be what you're looking for!
What You'll Do:
The Director, Engineering plans and directs all aspects of engineering (process engineering, automation engineering and packaging equipment engineering) activities within the organization. This individual is responsible for the design and implementation of manufacturing engineering plans and projects, quality requirements, and/or testing and troubleshooting systems. They will ensure all engineering projects, initiatives, and processes are in conformance with the organization's established policies and objectives. This individual will also ensure continuous improvement in process, cost, quality, and production. This group’s goal is to support the manufacturing and distribution of continued quality, innovative products.
As a member of the Operations leadership team, support the Vice President of Operations in the establishment and implementation of policies and strategic direction for the overall operation by developing plans, programs, and strategic vision for the department that will achieve the company’s yearly and long-term objectives.
Direct the functions of the Engineering area by implementing best engineering practices, utilizing most effective, preventive, and corrective maintenance, and assuring continued operations with minimal equipment and/or plant downtime:
Recommend appropriate corrective/preventive actions for existing equipment and manufacturing processes.
Maintain predictive/corrective/preventive maintenance efforts at all sites to ensure that equipment is available for manufacturing.
Establish and enforce project management discipline, policies, processes, and tools that enable world-class execution of the capital project portfolio.
Manage the engineering processes to ensure efficient operations and optimization of labor and equipment.
Develop and implement guidelines, standards, monitoring tools for evaluating programmatic and operational effectiveness and establish target metrics.
Identify efficiencies to reduce redundancy and/or elimination of tasks resulting in savings of cost, resources, and/or time.
Develop annual and long-term capital plans which are forward looking and reflect the needs of the organization. Align scope, schedule and budget with organizational objectives and prioritize the capital projects.
Maintain effective communications and relationships with stakeholders, leadership groups, cross-functional teams, internal customers, and vendors. Express ideas clearly and constructively (written and spoken, upward and downward, one-on-one and with groups). Seek to understand customer needs and work to exceed customer expectations (internal and external).
Develop, design, and execute all investments safely, within the allocated budget and schedule, in compliance with all National and Local codes and standards and in adherence to Company standards and guidelines assuring compliance with US, EU, ISO and cGMP and other regulations, as necessary. Clearly establish all documentation necessary per quality guidelines in order to obtain compliance.
Facilitate development of staff members to reach their full potential to enable them to meet company and personal goals. Guide departmental operations and personnel in accordance with the company guidelines by way of performance review, training and development programs, setting and tracking goals and objectives.
Understand and comply with ethical, legal, and regulatory requirements applicable to our business.
What You'll Bring:
Bachelor’s Degree in an Engineering field.
15-20 years of significant capital project and plant engineering experience (with increasing responsibilities) in the biologic or life science manufacturing arena.
10 years of managerial and leadership experience.
Ability to apply engineering principals to resolve issues relating to processing equipment, processing scale-up, technology transfer and related changes.
Knowledge of process control systems and automation.
Advanced knowledge of engineering design standards required for cGMP process and utility equipment.
Advanced knowledge of ISPE standards and FDA/EU regulations relative to facility and process.
Experience with commissioning and qualification of facilities and equipment.
Must have proven ability to manage staff and execute decisions, have strong budgetary skills, and work well with external vendors.
Master’s Degree in Engineering.
Experience in URS development, vendor selection and validation of production automation and equipment.
Strong aptitude towards root cause analysis and problem solving.
Ability to be accessible by staff, customers, outside vendors and key stakeholders as required. This may include nights, weekends, holidays, etc.
Ability to work with computers.
Ability to climb ladders occasionally.
Ability to lift 50 lbs.
Ability to drive.
Ability to travel nationally and internationally.
If you're looking for your next career step apply now! Questions? Feel free to contact Ginger Auchter directly: email@example.com