Maintenance

Description

• Directs, supervises, and instructs skilled craftsmen (Electrical, Calibration, HVAC/pipefitter and Machinist) and assures that all maintenance activities are consistent with regulatory codes and standards.
• This position is also responsible for Project Management of small to medium capital and expense projects for the site. Candidate must not be allergic to penicillin.

• Supervises and coordinates the activities of a skilled group of Maintenance colleagues
• Counsel, trains, and develops subordinates for efficient performance in their assignments and creates an atmosphere of team effort and open communication.
• Provides 24 hr screening of alarms and dispatch of maintenance personnel as On-Call supervisor every third week
• Visits job-sites (all areas of the plant including confined spaces) to direct and/or review troubleshooting, repair, or construction work.
• Manages the Corrective and Preventive Maintenance scheduling programs and assures that all records and documents for same are accurately maintained in an organized manner.
• Oversees the generation and distribution of a weekly schedule for planned maintenance as well as overdue listings for same.
• Develop, prioritize, and implement daily/weekly work schedules to ensure safe and efficient use of available resources.
• Coordinate with manufacturing supervision to assure repairs and preventative maintenance work orders are accomplished on time with minimal impact to production
• Writes work orders and purchases materials required for Maintenance operations.
• Order and maintain a specialized inventory of repair and replacement parts, which will support the plant's safety, quality, productivity, and delivery objectives.
• Prepares and supervises the completion and revision of effective maintenance procedures so that equipment, systems, processes, and facilities, perform as designed and validated. Follows change control procedures for changes to all departmental documentation systems.
• Responsible for supervising grounds maintenance contractors in order to maintain the appearance of the Rochester Plant grounds.
• Administers departmental procedures and union contract for maintenance technicians.
• Responsible for observing safe operating procedures and established safety rules.
• Follows site procedures for change control and provides documentation to Engineering and Validation on a timely basis for any design changes that are proposed or implemented.
• Provides information support during FDA and Quality Assurance audits.
• Review all relevant Engineering department SOPs on a bi-annual basis and revises as necessary to meet cGMPs and changes in practice.
• Reviews daily alarm logs and investigates and prepares alarm notification and response notices.
• Manages the conceptual design for small to medium plant capital and expense projects.
• Prepares project estimates and project schedules.
• Estimates operational cost savings for capital and expense projects
• Works with vendors and engineering service firms in the development of equipment and facility specifications
• Assess project impact on cGMP and validation status and provide supporting documentation as required.
• Responsible for all project objectives such as safety, budget, schedule and quality.
• Coordinates with engineering firms, or contractors for required support needed to achieve project objectives.
• Addresses project issues by analysing and implementing appropriate solutions
• Coordinates project meetings and prepare project status reports.
• Responsible to properly close-out assigned projects.

• REQUIRED Associates Degree in Engineering Technology or related field preferred but will consider Journeyman status or equivalent combination of education and experience.
• DESIRED-Bachelor's Degree in Engineering or related field.
• Minimum of six years experience in pharmaceutical facilities and equipment
• Knowledge of GMP, OSHA and FDA regulations applicable to the pharmaceutical industry
• Experience in reliability based maintenance practices a plus
• Analytical - Collects and researches data; gathers and analyzes information skillfully; good organizational skills; approaches problems objectively and systematically; draws accurate conclusions from complex information.
• Reasoning Ability - Demonstrates ability to define problems, collect data, establish facts, and draw valid conclusions from an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Customer Service - Responds to requests for service and assistance.
• Utilizes knowledge of workflows to proactively identify and address issues that may affect service to the customer; steps in to handle escalated issues that arise, communicating directly with customers as needed, and takes appropriate steps to promote efficient workflows/customer service; builds trust/credibility with customers by demonstrating commitment to achieving mutual goals.
  Interpersonal - Interfaces with members of management and non-management employees; actively contributes to building a high performance culture and a positive work environment.
• Oral Communication - Listens/gets clarification; responds well to questions.
  Team Work - Exhibits objectivity and openness to others' views; takes personal accountability for contributions to team and organizational results; initiates collaborative efforts across the department; uses influence - up, down & sideways - to build strong business practices to get results.
• Written Communication - Writes clearly and informatively; presents numerical data effectively; able to read and interpret written information.
• Diversity - Shows respect and sensitivity for personal and cultural differences; values multiple viewpoints and is sensitive to factors (race, gender, age, culture, and religion) that may affect behavior and feelings.
  Ethics - Works with integrity and ethically; maintains confidentiality.
• Organizational Support - Follows policies and procedures; takes initiative, risks, and assumes personal responsibility to achieve organizational goals.
• Adaptability - Adapts to changes in the work environment; able to handle multiple tasks simultaneously, and works with a sense of urgency in meeting or exceeding deadlines; open to change, new ideas and different perspectives.
• Dependability - Takes responsibility for own actions; achieves goals by being resourceful, reliable, and follows through on commitments.
• Innovation - Displays original thinking and creativity.
• Judgment - Exhibits sound and accurate judgment; anticipates and resolves problems objectively and quickly eliminates barriers to progress; actively seeks, considers and incorporates others' ideas when making decisions.
• Professionalism - Treats others with respect and consideration regardless of their status or position; behaves in accordance with clear professional and appropriate ethical standards; consistently follows through on commitments and is seen as reliable by coworkers; respects all colleagues and holds others and self to same high standards.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality.
  Safety and Security - Observes safety and security procedures; responsible for meeting department safety objectives and follows on-going safe operating procedures consistent with the job requirements.
• Computer Skills - Must have advanced computer skills including familiarity with Microsoft Office Suite programs.
• Demonstrate knowledge in GMP, environmental, health and safety procedures to assure regulatory, policies and/or guidelines compliance.
• Observe and notify any risk situation for the environment, health or safety.
• Assure that all energy conservation initiatives comply with all regulatory agency requirements.