Manager/TL, Maintenance and Reliability – Aseptic Facility/Utility Area

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows

ROLE SUMMARY

Responsibilities include management of all maintenance engineering activities to ensure the facility and utility machinery and equipment for aseptic operations are performed with the highest degree of reliability and cost efficiency. Responsible to ensure the efficient planning and execution of maintenance activities while maintaining cGMP and Safety Compliance as the highest priorities. Additional responsibility includes designation of team members who will act as single points of contact for all engineering issues that impact or can potentially impact operations, i.e. environmental or facilities conditions, in order to streamline communications with the proper engineering resources and our operational partners.

ROLE RESPONSIBILITIES

Responsible to oversee the facility and utility maintenance activities for the Aseptic operations and aseptic support facilities including but not limited to Leadership and Administrative, Operational Management, Good Manufacturing Practices and Environmental, Health and Safety duties.

Leadership and Administrative:

1.        Ensure a safety and compliance culture is maintained as the highest priorities at all times by holding regular safety talks, ensuring team safety meeting attendance, ensuring all tools are available to perform work safely and efficiently, and by holding team members accountable for demonstrating our safety culture every day.

2.        Manage maintenance organization to comply with Kindeva policies, guidelines and procedures

3.        Rigorously drive colleague development through execution of a robust training matrix which assesses team members periodically and provides direction for training and development needs.

4.        Ensure proper utilization of maintenance resources.

5.        Administer the development and implementation of the maintenance programs for the Aseptic operations.

6.        Develop and/or evaluate methods and procedures for improving maintenance operations.

7.        Approve the selection of new maintenance personnel.

8.        Promote colleague engagement and development consistent with the Kindeva IDP process and other engagement programs.

Operational Management:

1.        Establish the maintenance goals and metrics and provide direction to personnel to align with departmental goals and/or objectives.

2.        Provide technical support to identify innovative engineering solutions for site machinery or equipment issues and ensure implementation in a timely and professional manner.

3.        Approve or suggest major equipment changes or improvements.

4.        Approve or suggest preferred vendors for equipment , parts and instrumentation.

5.        Ensure maintenance work costs do not exceed approved budget.

6.        Lead the maintenance planning group in setting priorities for maintenance work.

7.        Appoint single point of contact for all operational shifts including weekend and holidays to ensure coordination with other engineering sections or contractors for any support needed to ensure continuous operations.

8.        Monitor, review and approve spare parts listing and inventory.

9.        Coordinate team meetings and share maintenance engineering metrics, reliability reports, production priorities, and other company news and information.

10.        Review and/or approve the use of outside consultants/contractors  to support maintenance engineering  activities.

11.        Assist in the review of all maintenance engineering documents to comply with codes and regulatory requirements of U.S. authorities.

12.        Responsible for ensuring maintenance procedures are current and up to date.

Good Manufacturing Practices:

1.  Comply with the current Good Manufacturing Practices (cGMP).

Environmental requirements:

1.        Demonstrate knowledge in GMP, environmental, health and safety procedures to assure regulatory, policies and/or guidelines compliance.

2.        Observe and notify any situations that identify risks for the environment, health or safety.

3.        Implement a safety program to insure a safe operation of the facilities and maintenance engineering group.

BASIC QUALIFICATIONS

Education: Bachelor’s degree in Engineering or 15 years supervisory experience in aseptic operations/maintenance.

Experience:

•        At least ten (10) years of experience in Maintenance Engineering.

•        Knowledge of FDA, OSHA or EPA regulations applicable to the pharmaceutical industry.

•        Strong managerial and supervisory experience in Maintenance Engineering.

California residents should review our Notice for California Employees and Applicants before applying. 
 
Covid-19: