Director of Engineering & Facilities
Company Name:
Independent
Kremers Urban (KU) Pharmaceuticals is a multinational pharmaceutical company. We strive to serve unmet medical needs by developing and marketing innovative products for specialty markets. We are committed to providing excellent services to our customers and creating significant value for our investors.
We foster an employee culture that remains focused on the individuality of each employee and the unique contribution value that each person can bring to KU.
Objective
The Director of Engineering & Facilities is responsible for planning and directing maintenance, plant engineering, new construction, equipment validation and EH&S activities.
The group's goal is to support the mfg of quality pharmaceuticals in compliance with US, EU, Chinese and Japanese cGMPs and other regulations as necessary.
Responsibilities
Develop plans and programs for the department that will achieve the company's yearly and long term objectives.
Develop long term and annual capital plans which are forward-looking and reflect the needs of the site.
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.
Maintain the predictive/corrective/preventive maintenance and metrology effort at the site to ensure that equipment is available for manufacturing.
Maintain site compliance with EH&S related government agencies.
Maintain a high safety standard within the department by personal example and adherence to company safety standards.
Provide the long and short-range strategic vision, plan and direction for the department.
Guide departmental operations and personnel in accordance to the company guidelines by way of performance review, training and development programs, setting and tracking goals and objectives.
Effectively manage approximately 9 direct reports and 28 indirect reports.
Facilitate development of staff members to reach their full potential to enable them to meet company and personal goals.
Qualifications/Experience
15 years of plant engineering experience in pharmaceutical manufacturing arena (preferred solid oral dose).
7 years of managerial and leadership experience preferred.
Knowledge of applicable regulatory standards (FDA, CFR, OSHA, EPA, etc.)
Advanced knowledge of engineering documentation required for cGMP process and utility equipment.
Advanced knowledge of ISPE standards and FDA/EU regulations relative to facility and process.
Ability to apply engineering principals to resolve issues relating to processing equipment, scale, technology transfer and related changes.
In-depth knowledge of process control systems and automation.
Kremers Urban offers competitive packages (medical, vision, dental, vacation, paid holidays and 401(k), growth potential, and a challenging and exciting work environment.
Should you have interest in joining our team, feel free to apply to http://www.kremersurban.com/careers/Careers.aspx.
KU is an equal opportunity employer, committed to a drug free workplace.Estimated Salary: $20 to $28 per hour based on qualifications.
Independent
Kremers Urban (KU) Pharmaceuticals is a multinational pharmaceutical company. We strive to serve unmet medical needs by developing and marketing innovative products for specialty markets. We are committed to providing excellent services to our customers and creating significant value for our investors.
We foster an employee culture that remains focused on the individuality of each employee and the unique contribution value that each person can bring to KU.
Objective
The Director of Engineering & Facilities is responsible for planning and directing maintenance, plant engineering, new construction, equipment validation and EH&S activities.
The group's goal is to support the mfg of quality pharmaceuticals in compliance with US, EU, Chinese and Japanese cGMPs and other regulations as necessary.
Responsibilities
Develop plans and programs for the department that will achieve the company's yearly and long term objectives.
Develop long term and annual capital plans which are forward-looking and reflect the needs of the site.
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.
Maintain the predictive/corrective/preventive maintenance and metrology effort at the site to ensure that equipment is available for manufacturing.
Maintain site compliance with EH&S related government agencies.
Maintain a high safety standard within the department by personal example and adherence to company safety standards.
Provide the long and short-range strategic vision, plan and direction for the department.
Guide departmental operations and personnel in accordance to the company guidelines by way of performance review, training and development programs, setting and tracking goals and objectives.
Effectively manage approximately 9 direct reports and 28 indirect reports.
Facilitate development of staff members to reach their full potential to enable them to meet company and personal goals.
Qualifications/Experience
15 years of plant engineering experience in pharmaceutical manufacturing arena (preferred solid oral dose).
7 years of managerial and leadership experience preferred.
Knowledge of applicable regulatory standards (FDA, CFR, OSHA, EPA, etc.)
Advanced knowledge of engineering documentation required for cGMP process and utility equipment.
Advanced knowledge of ISPE standards and FDA/EU regulations relative to facility and process.
Ability to apply engineering principals to resolve issues relating to processing equipment, scale, technology transfer and related changes.
In-depth knowledge of process control systems and automation.
Kremers Urban offers competitive packages (medical, vision, dental, vacation, paid holidays and 401(k), growth potential, and a challenging and exciting work environment.
Should you have interest in joining our team, feel free to apply to http://www.kremersurban.com/careers/Careers.aspx.
KU is an equal opportunity employer, committed to a drug free workplace.Estimated Salary: $20 to $28 per hour based on qualifications.
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