Production Engineer / Capital Project focus (Updated role description)
We strive to make lives better by bringing quality, affordable self-care products that consumers trust everywhere they are sold. Help us do it.
This Production Engineering role in our Holland MI manufacturing plant will:
Provide technical support to consumer healthcare operations through the support and execution of capital projects and by providing a technical resource for the processing and packaging of drug products.
Provide production engineering support for day-to-day operations of a lean six sigma pharmaceutical manufacturing facility.
Initiate and drive continuous improvement efforts in assigned process area.
- Bachelor’s degree in engineering required along with a minimum of 4 years of applied work experience.
- Demonstrated experience with quality systems in an FDA current GMP regulated environment as well as capital project management experience is highly desired.
- Approximately 25% of this individual’s time will be spent on Capital Equipment Project Management and the remaining 75% of the time will be spent on Production Engineering Support.
- Provides leadership in the development and implementation of capital projects and functions as project engineer and project manager by providing work direction to project teams and allied support groups while interfacing with multiple departments, consultants, and contractors.
- Manages and coordinates the engineering design and construction of capital projects and provide expert engineering support in developing and implementing equipment installations, process improvement, and facility, utility, and maintenance projects to support manufacturing and packaging operations.
- Organizes and generates all relevant data to prepare project scopes, cost estimates, economic justifications, and capital appropriation requests, as required, to obtain management approval.
- Acts as technical expert with a broad knowledge and deep expertise of the latest equipment technologies for dosage form manufacturing and packaging, demonstrates an expert understanding of engineering theoretical fundamentals of equipment operation, and demonstrate full use of advanced principles, theories, concepts and techniques in creative and novel ways to solve complex technical problems
- Demonstrates an expert proficiency in the ability to read, understand, and create drawings, flowcharts, sketches, schematics, and other engineering design documentation, ensures the fulfillment of Perrigo Quality requirements for compliance with cGMP regulations including equipment qualification (IQ/OQ/PQ) and change control activities, and follows Perrigo policy and procedure along with current industry standards to prepare or assist with the preparation of system design documentation including User Requirements Specifications (URS) and Functional and Design Specifications (FDS) in accordance with established Good Engineering Practice (GEP).
- Excellent problem-solving skills, sound decision-making skills, and demonstrated ability to meet deadlines in a team-oriented environment.
- Knowledge and ability to apply Lean Sigma principles highly preferred.
- Established understanding of engineering theoretical fundamentals of equipment operation and demonstrate the use of standard principles, theories, concepts and techniques.
- Hands-on knowledge of production operations and associated control systems preferred.
- Well-developed analytical skills including the ability to develop sound economic analyses with prudent financial judgment.
- Ability to work toward broad goals and to exercise initiative in identifying projects.
- Well-developed ability to maintain composure and patience during challenging situations and the ability to cope with shifting priorities and adapt quickly to remain productive.
- Ability to react to new demands, priorities, and challenges or obstacles in a resourceful and constructive way.
- Ability to work effectively with interdisciplinary groups or project teams, and relate well to people regardless of their organizational level, personality, or background.
- Ability to act in an ethical and open manner and consider the impact of decisions.
- Support operations to meet applicable laws such as: OSHA, Environmental, Safety, cGMP as well as Corporate and Site Quality requirements.
We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better.
Due to the highly regulated pharmaceutical industry and legal requirements, you may be subject to post employment background checks.