Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.
Job Description Summary
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.
Job Description
Scope of Authority
- span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Assigned U.S. based manufacturing site.
Key Accountabilities
- key outcomes/deliverables, the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
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.
50%
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.
35%
People Management
- Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution maintenance staff.
- Ensures that all staff are 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.
10%
Budget
- Accurately forecasts manufacturing maintenance budget needs.
5%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
- 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.
Knowledge
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, 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
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
- 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, collect 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.
Physical Requirements
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
- 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 abilities required by this job include color vision
- Occasionally exposed to moving mechanical parts; outside weather conditions and risk of electrical shock.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.