Qualitest Pharmaceuticals, Inc.
Rochester, MI, United States
Engineering, Manager, Bluecollar, Chemistry, Sciences
May 30, 2020
Sep 12, 2020
Manager, Maintenance Engineering
About Endo International plc
Endo International plc (NASDAQ: ENDP) is a highly focused generics and specialty branded pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA, employing approximately 3,000 people worldwide. For 2018 Endo, reported revenue of $2.947B and adjusted diluted EPS of $2.89. Learn more at www.endo.com.
The Manager, Maintenance Engineering oversees the staff and maintenance of equipment and facilities. This includes systems utilized by the maintenance department to monitor and control environmental condition and processes (i.e. BAS, Calibration, PLC, and control systems). This position will work with the operations managers and supervisors to prioritize work activities and dispatch the correct trade in a timely manner.
ROLE AND RESPONSIBILITIES:
Equipment and Facilities Maintenance
Assures that equipment is maintained in accordance with all cGMP, OSHA, governmental, and corporate standards.
Directs engineering investigations and prepares written reports when product-related equipment and system abnormalities occur.
Oversees the operation of the WFI, clean steam, compressed air, and nitrogen systems.
Monitors and prioritizes maintenance needs and assigns work as priorities dictate.
Investigates and analyzes accidents involving equipment and systems; takes appropriate corrective actions to eliminate safety hazards; and completes any required documentation in a timely manner.
Actively participates in regulatory and contract customer audits involving equipment.
Collaborates with Tech Ops and Manufacturing to support project work and new equipment FATs to ensure a smooth transition of equipment and process to operation.
Coordinates activities with the EHS team to assure that new and existing equipment applications are designed to minimize personnel safety hazards.
Misc. Support and Communication
Leads and/or actively participates in the project management of new product and process implementations.
Collaborates with Manufacturing, Pharmaceutical Technology, and Quality Operations to control and reduce production variances.
Supports project work of PMO office as needed.
Provides regular reports to communicate departmental activities, project status, and events that impact manufacturing operations.
Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution maintenance staff.
Ensures that all staff
trained on the most updated version of the operating procedures.
Hires, trains, and manages performance of staff.
Sets goals and objectives for individuals and teams.
Identifies and evaluates employee training requirements.
Delegates work duties to individual staff members.
Accurately forecasts manufacturing maintenance budget needs
Bachelor of Science degree in Chemical, Mechanical, or Electrical Engineering or related studies required with 10 years’ progressive technical experience OR
MS with 8 years’ experience as noted above.
Previous facility/production maintenance experience in a cGMP or regulatory environment is preferred.
Previous supervisory experience is preferred.
Pharmaceutical industry experience is preferred.
Hands-on experience working with industrial automation such as Programmable Logic Controller (PLC), Variable Frequency Drive (VFD), etc.
Strong knowledge of Manufacturing processes and equipment.
Knowledge of pharmaceutical QMS requirements for change control, investigations, and good documentation practices.
Knowledge of Blue Mountain Regulatory Asset Management or equivalent Program
Knowledge of Building Management Systems, including State and County codes.
Skills & Abilities
Expertise with Microsoft software (e.g. Word, Excel, Project, PowerPoint, Outlook, Visio).
Must have the ability to work effectively with a computerized maintenance management system and instruct others on its operation.
Able to understand and follow oral and written instructions.
Able to communicate clearly and concisely, both oral and writing.
Ability to define problems,
data, establish facts, and draw valid conclusions and deal with several abstract and concrete variables.
Ability to plan and manage multiple projects simultaneously.
Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes oneself available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Will sit or stand for long periods of time throughout the day.
Required to lift up to 50 lbs.
Will walk and climb stairs.
Will reach over shoulder heights and below waist.
Required to use hands to lift, handle, carry or feel.
May be required to kneel, bend, talk and hear.
The noise level in the work environment is usually moderate
Specific vision ab
ilities required by this job include color vision
Occasionally exposed to moving mechanical parts; outside weather conditions and risk of electrical shock.
Afternoon shift premium is 10% (non-union position
Midnight shift premium is 15% (non-union positions only)
Endo recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Qualitest Pharmaceuticals, Inc.
Website : http://www.qualitestrx.com/