Facilities Engineer

SUMMARY

This position is responsible for supporting operations by ensuring that the building and utilities are properly maintained to support GMP manufacturing and general facility operations. This support includes performing building and utility equipment inspections, diagnosing problems, scheduling, coordinating and overseeing third party maintenance activities, performing hands-on maintenance, and completing and reviewing GMP and non-GMP documents relating to change controls. He/she will work closely with CMC personnel to ensure the facility and equipment is kept in an inspection ready condition.

This role requires creative and collaborative interfacing with CMC stakeholders, facility operations and facility engineering teams. Scope of work includes championing effective equipment / utility maintenance practices and strict adherence to GMP requirements.

DUTIES AND RESPONSIBILITIES

• Understand core CMC goals and operations to ensure maintenance strategies mesh with stakeholder requirements and business needs.
• Oversee the building and utility maintenance program in accordance with GMP and GDP requirements to achieve a high level of equipment reliability and inspection readiness.
• Assess repair effectiveness against preventive maintenance strategies, and develop and/or enhance PMs accordingly.
• Investigate equipment and utility deficiencies using root cause analysis, creative problem-solving techniques, and technical expertise to identify and resolve causal factors.
• Schedule, oversee and verify 3rd party manufacturing equipment / utility (mechanical, HVAC, electrical, gases) / building maintenance activities. Obtain and process vendor quotes for repairs and services.
• Lead or assist with building/utility-related projects.
• Respond to after-hours building and utility alarms on a rotational basis.
• Perform daily inspection of buildings and utility equipment to proactively identify and document areas of concern.
• Own and manage the compressed gas program
• Initiate and participate in GMP investigations, deviations, CAPAs and change controls related to building, utility and equipment repairs. Develop and modify SOPs related to equipment maintenance
• Assist with building support services
• Occasionally perform building and utility maintenance, such as patching / painting, filter replacement, etc. Some work may be required in a GMP clean room (gowning required).
• Supervise the activities of 3rd party service providers. Escort and oversee activities, including those in a cleanroom. Ensure documentation is completed at the time of service and that work is performed in accordance with US WorldMeds EHS/GMP requirements.
• Effectively align maintenance activities with stakeholder schedules to ensure the maintenance (or repairs) is performed before the due date and without disrupting the manufacturing schedule.
• Maintain the preventive maintenance program. Review and assess equipment history for reliability concerns. Evaluate maintenance strategies against equipment performance and recommend improvements to the PM strategy.
• Identify and maintain stock of critical spare parts and stand-by equipment needed to assure maximum capacity and reliability.
• Ensure appropriate vendor service contracts are in place to support the maintenance program including timely raising of new / modified service contracts and issuance of P.O.s.
• Perform minor carpentry, patching, painting and other building services to ensure building is in an inspection ready state.
• Respond to equipment and utility emergencies after hours.
• Review BAS information to assess HVAC performance and operational conditions. Acknowledge alarms in the BMS.
• Oversee the utility and building maintenance program, including preventive and corrective maintenance programs. Some maintenance activities will be performed in a clean room.
• Lead or assist with Facilities and Engineering projects, including equipment installations and HVAC upgrades.
• Review drawings, develop schedules, and coordinate project related activities with stakeholders.
• Confirm work is performed as designed.
• Perform all activities in compliance with applicable cGMP regulations, FDA, USP and ISPE guidelines
• Organize and clearly document maintenance records in inspection ready state
• Participate in and/or initiate GMP investigations, deviations, CAPA, and change control related to maintenance.
• Champion GMP compliance and maintenance best practices to support a best-in-class maintenance program.
• Identify and recommend initiatives for continuous improvement, including developing or modifying SOPs.
• Perform daily, weekly and quarterly building and manufacturing equipment inspections to proactively identify maintenance issues.
• Review and modify relevant SOPs as needed to effectively perform inspections.
• Document findings at time of inspection
• Note areas of concern, initiate work orders, schedule repairs and track to completion.
• Oversee and change out compressed gases on process equipment.
• Assist building support services in setting up conference rooms, meetings, events, hanging white boards, kitchen and office inventory, etc.
• Other duties as assigned by management in support of rapidly growing company.

QUALIFICATIONS

• Maintenance experience with a wide range of building and equipment systems within a GMP manufacturing environment.
• Experienced with GMP Quality Management system (deviations, CAPA's, etc.).
• Strong ability to analyze raw data, assess results and determine appropriate action.
• Ability to consistently apply work methods with precision and accuracy to ensure quality results.
• Experience completing GMP documentation related to maintenance activity.
• Ability to successfully organize maintenance requirements using excel spreadsheets or software tool to ensure all work is performed within due dates.
• Must have strong organization skills and a resilient mentality to be able to rapidly adjust and accommodate conflicting priorities and sudden scheduling changes.
• Capable of successfully working independently with limited supervision as well as in a collaborative environment.
• Highly collaborative and supportive of business and of its ideals and strategies
• Prior experience in complex biotechnology and / or pharmaceuticals industry

COMPETENCIES

• 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.
• Analytical- Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.
• Attendance/Punctuality- Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Business Acumen- Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals
• Computer Skills- Skilled with computers; Takes advantage of new technology; Learns new tools quickly; Uses technology to enhance job performance.
• Conflict Management - Good listener; Committed to finding solution to problems; Works well with people.
• Customer Service- Manages 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.
• Decision Making- Able to reach decisions; Takes thoughtful approach when considering options; Seeks input from others; Makes difficult decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions.
• Dependability- Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Design- Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
• 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.
• Interpersonal Skills- Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.
• Initiative- Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• 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.
• 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.
• Motivation- Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
• Oral Communication- Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
• Organizational Support- Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organizations goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Planning/Organizing- Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Professionalism- Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
• Problem Solving- Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Project Management- Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
• Quality- Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quantity- Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
• Quality Management- Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness
• Strategic Thinking- Develops strategies to achieve organizational goals; Understands organizations strengths & weaknesses; Analyzes market and competition