Manager, Sanitation & Sterile Fill Mfg

Manufacturing & Packaging Rochester, Michigan


Description

Manager, Sanitation and Bulk Manufacturing, Operations and Manufacturing, Michigan-Rochester

 

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.

 

POSITION SUMMARY:

The Manager, Sanitation and Bulk Manufacturing is responsible for operations utilizing hourly union operators that perform: 1) environmental cleaning and sanitization of areas, as well as general housekeeping for the entire facility, 2) dispensing of excipients and active pharmaceutical ingredient samples and quantities for production, and 3) compounding and/or filtering drug product for fill/finish operations.  Production includes a variety of drug and biological products, including Par branded, development  and generic as well as contract customer products; operations conducted while meeting department quality, safety, delivery and productivity objectives.    Establishes objectives for the department and metrics reporting.  Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract.  Responsible for oversight of group leaders and supervisors in Sanitation and Bulk Manufacturing.  Ensures compliance with documentation reviews, training, and change control.  Initiates, and/or reviews and approves department standard operating procedures, investigations, and change controls to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Sterile Operations, Process Development, and Supply Chain to meet plant objectives.

In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Manager of Bulk Manufacturing and Sanitation at Rochester, MI manufacturing plant; responsible for 2-4 supervisors and personnel across 2-3 shifts; budgetary responsibility ~$4M; spend signing authority up to $10K/PO. Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice. Significant equipment includes: Isolators, Scales, Tanks, etc.

 

ROLE AND RESPONSIBILITIES:

Operations

  • Runs operation to meet or exceed delivery performance objectives for product or projects
  • Responsive to changes in daily workflow and schedule; determines needs  and redeploys resources and/or overtime  to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation
  • Ensure all equipment is working properly
  • Maintains a safe work environment
  • Backs up Supervisor duties and responsibilities as needed

 

Compliance

  • Understands and adheres to good documentation practices (GDP)
  • Drives Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure
  • Confidently demonstrates knowledge and executes proficiently in at least one QMS area: deviation management and/or change control
  • Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure.  Approves investigations and/or change control plans
  • Counsels, trains, and develops Group Leaders, Supervisors, and union colleagues for efficient performance; creates an atmosphere of team effort and open communication
  • Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes
  • Approves Maximo work orders
  • Creates, reviews, approves, and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety
  • Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance
  • Follow and comply with company Safety policies and OSHA Regulations
  • Participates in development and maintenance of a safe manufacturing environment.  Establishes methods in compliance with regulatory, plant, and corporate policies.  Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions

 

Supervisory

  • Reports daily production updates at daily Huddle or SMART meetings
  • Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations
  • Direct manpower as needed, resolve conflict and assume all aspects of leadership including oversight of disciplinary actions
  • Monitor performance and attendance of all Bulk and Sanitation personnel
  • Makes personnel utilization decisions and PTO requests based on total queue, backlog, and resource capacity
  • Assigns projects for continuous improvement
  • Requests equipment and facility repairs, or modifications
  • Understands and complies with Union Agreement

 

Leadership

  • Develops and reports departmental metrics
  • Participates in recruitment, selection, promotion, and retention of personnel
  • Reviews operational performance; drives improvement opportunities
  • Recognize and reward employees that consistently perform at high levels or go above and beyond their required job duties in order to maintain a high level of employee morale
  • Consistently communicate, follow and enforce SOP’s and company policies and guidelines set forth in the employee handbook
  • Identify developmental needs of others; provide coaching, mentoring, and encouragement to help others to improve their knowledge or skills
  • Provide regular coaching and performance feedback to employees in addition to conducting annual performance reviews.  Recognize and implement performance improvement plans when needed in consultation with Human Resources Business Partner
  • Troubleshoots or resolves issues impeding department objectives/deliverables; proactively demonstrates the ownership to achieve
  • Interfaces with suppliers of equipment or products and area consultants/experts
  • Conducts/supports CMO audits or regulatory agency inspections

 

REQUIRED QUALIFICATIONS:

Education & Experience

Education

  • Required- B.A. /B.S. Degree in Science, Business or related field or significant experience.
  • Desired- B.A. /B.S. Degree in Science and/or Management degree

Experience

  • Required – 2 years minimum as a Supervisor in Operations, or Quality department with increasing levels of responsibility or equivalent
  • Desired – 2 years as an Operations Supervisor or equivalent experience with QMS (deviation/change control) and project management

 

Knowledge

  • Knowledge of Enterprise Resource Planning tools (JD Edwards); Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite, ADP Vantage, Maximo, etc.
  • Solid understanding of all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA

 

Skills & Abilities

To perform the job successfully, an individual should demonstrate the following competencies:

For internal candidates: meets or exceeds expectations for competencies outlined in the Supervisor and Sr. Supervisor Sanitation/Bulk Manufacturing Job Descriptions in addition to the following:

  • Project ManagementDevelops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities
  • Change ManagementDevelops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
  • Managing PeopleIncludes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self 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
  • Quality ManagementLooks for ways to improve and promote quality; Demonstrates accuracy and thoroughness
  • Cost ConsciousnessWorks within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources
  • JudgementDisplays 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
  • Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention

To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:

  • Customer ServiceManages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments
  • Visionary LeadershipDisplays passion and optimism; Inspires respect and trust; mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates
  • DelegationDelegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results
  • LeadershipExhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
  • Business acumen- Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals
  • Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce
  • Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values
  • Organizational supportFollows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity
  • Strategic ThinkingDevelops strategies to achieve organizational goals; Understands organization's strengths and weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions

 

PHYSICAL REQUIREMENTS:

  • Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5
  • Stand, Walk, Sit, Talk and/or Hear
  • Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.
  • Specific vision abilities required by this job include close vision
  • Frequently working near or exposed to moving mechanical parts
  • The noise level is moderate
  • Occasional exposure to fumes, airborne particles, toxic or caustic chemicals
  • Work environment is a production/manufacturing plant

 

ADDITIONAL INFORMATION:

  • Afternoon shift premium is 10% (non-union positions only)
  • 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

 

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