Are you ready to take the lead in a dynamic, fast-paced environment? We are seeking a dedicated and experienced Supervisor / Senior Supervisor for our day shift production team. This role is a unique opportunity to contribute to our ambitious sustainability strategy and make a real difference in our Operations department.

Lead Process Engineer

Brief Description:

Process Engineering is responsible for providing technical support to the manufacturing and logistics buildings at the Frederick Manufacturing Center (FMC) for troubleshooting, modifications and improvements related to process, clean-in-place, steam-in-place, washing, and sterilizing equipment systems.

Core Responsibilities:

Scope

• Select, design, and implement new/replacement systems as required for existing or new (tech transfer) processes, equipment, and automated systems; continuous improvement initiatives; and Asset Life Cycle Management.
• Resolve technical issues, identifying root causes and defining corrective/preventive actions with equipment and automated systems.
• Lead assigned change controls associated with equipment and automated systems.
• Possess some technical skills and knowledge with biopharmaceutical operations, process/utility equipment, and automated systems.
• Create/update equipment and automated systems operation and maintenance documentation and training materials.
• Identify/update spare parts and preventive maintenance procedures for new/modified equipment and automated systems.
• Support FAT, SAT, commissioning, and validation activities for assigned equipment and automated systems.
• Possess some understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation.
• Develop capability to provide technical support during audits and inspections.
• Develop capability to train necessary staff on equipment operation.
• Understand importance of safety in the workplace and contribute to safety awareness in the department.
• Understand importance of quality in the workplace and contribute to quality awareness in the department.

Projects/Activities

• Efficiently and effectively manage assigned projects and initiatives.
• As required by group, assist Senior and Principle Engineers on more complex projects/initiatives.
• Manage of internal and external resources for assigned projects/initiatives.
• Contribute to functional and departmental development and Lean initiatives.

Knowledge

• Fundamental understanding of biopharmaceutical processes and equipment through coursework or previous work experience. 
• Develop an understanding of equipment, processes, and automated system design through coaching and support.
• Familiarity with common business systems and processes.
• Understanding of Lean concepts and waste reduction.
• Develop understanding of GMP requirements and engineering fundamentals.
• Effective working knowledge and experience relevant to at least one technical discipline and/or therapeutic area.
• Develop understanding of project management methodologies and tools to advance assigned projects.
• Develop organizational awareness.

Problem Solving

• Provide solutions to a variety of technical problems of moderate scope and complexity, which are verified by supervisor for technical accuracy and merit.
• Develop understanding and use of 5 Whys, Level-0, and Practical Problem Solving.
• Demonstrate rudimentary problem-solving skills related to finite troubleshooting and project execution challenges.
• Emerging understanding of how the stakeholder organization(s) functions and who should contribute to a problem-solving process.
• Emerging understanding of how to balance and integrate core function and project objectives.
• Coordinate risk mitigation and contingency scenarios for projects and ensure practical implementation of agreed recommendations.
• Demonstrate a composed manner when dealing with issues, challenges, conflicts, and opportunities.
• Be creative and flexible in identifying and implementing solutions.
• With guidance and coaching, able to contribute and apply learnings and best practice from projects/activities and share with group and colleagues.
• Support 24X7 operations as on-call support

Freedom to Act

• Work under general supervision for activities and to meet goals and objectives.
• Follow established procedures and guidelines.
• Work is reviewed/monitored for soundness of technical judgment, overall adequacy, accuracy, and completeness.
• Lead moderate cross-functional teams to complete work.
• Self-starter.
• Identify issues and seek input from manager for appropriate resolution.
• Expected to prioritize and organize activities effectively to align with the needs of the group and established goals and objectives.
• Empowered to work within the organization to ensure the progression of assignments.

Impact

• Contribute to the completion of milestones associated with specific activities.
• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
• Progress assigned activities through key milestones on time and to budget to meet required deliverables.
• Develop goals that align and support department goals and priorities.
• Understand how to work within their department and be a good ambassador for your group.
• Seek opportunities to develop expertise within your group and enhance your professional reputation though learning, continuous improvement, and applying best-practices.

Interpersonal/Communications

• Primarily internal company contacts, with some interaction with vendors and contractors.
• Frequent interaction within teams across departments.
• Possess ability to convey ideas and concepts to others.
• Apply stakeholder management principles within a matrix environment building productive relationships with key interfaces and stakeholders.
• Use appropriate communication techniques/tools to work effectively and collaboratively in a complex manufacturing environment.
• Abiility to negotiate with customers and stakeholders using decision making tools (DAI).

Systems

Proficient in computer skills and MS Office applications.

Special Skills:

• Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).
• Knowledge of the product flow through the various production areas.
• Basic understanding of PLC and distributed control systems, HMIs, and data historians.
• Familiar with the operation and maintenance of process equipment in either production area:
  • Upstream equipment:
    • Incubators
    • Bioreactors
    • Centrifuges
    • Pasteurizer
  • Downstream equipment:
    • Chromatography columns
    • Viral inactivation
    • Ultrafiltration
    • Diafiltration
    • Freeze/thaw
• Basic understanding of engineering principles (fluid dynamics, heat transfer, etc.) and how they are applied to the operation of the production equipment.
• Familiar with the cleaning and sterilization strategy for process vessels and transfer lines.
• Ability to use process data (i.e., temperatures, pressures, valve sequencing, etc.) to solve equipment-related issues.
• Familiar with regulatory audit process and capable of gathering supporting documents.

Minimum Requirements

Bachelor of Arts or Science in Engineering or Life Sciences

5 years or more of applicable experience

3 years or more of pharmaceutical, biotech or life sciences experience

The annual base pay for this position ranges from $108,194- $162,291. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

Closing Date