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Sr Facilities Engineer

US WorldMeds
100000.00 To 125000.00 (USD) Annually
United States, Pennsylvania, Philadelphia
Jan 22, 2026

SUMMARY:

The Sr. Facilities Engineer is responsible for ensuring that all process equipment and critical utilities are maintained in a qualified, calibrated, and compliant state to support GMP manufacturing and overall facility operations. This role independently performs and oversees complex process equipment and utility calibrations, troubleshooting, and repairs while ensuring adherence to cGMP, regulatory, and company quality standards.

The position serves as a subject matter expert for process equipment reliability, supporting cross-functional root cause investigations related to equipment failures, deviations, and performance issues. Responsibilities include diagnosing technical problems, developing corrective and preventive actions (CAPAs), scheduling and coordinating third-party calibration and service providers, and ensuring timely execution of maintenance and calibration activities.

In addition, the Sr. Facilities Engineer drives continuous improvement initiatives to enhance the robustness, efficiency, and compliance of the calibration and maintenance programs, advancing the organization toward a higher level of commercial readiness. This includes optimizing calibration strategies, improving documentation and data integrity, strengthening preventive maintenance programs, and supporting equipment lifecycle management to ensure long-term operational reliability and inspection readiness.

DUTIES AND RESPONSIBILITIES:

  • Partner with CMC, Manufacturing, Quality, and Facilities teams to understand core business objectives and ensure calibration and maintenance strategies align with operational, regulatory, and commercial readiness requirements.
  • Own and oversee the utility and process equipment calibration program in compliance with cGMP and GDP requirements, ensuring a high level of equipment reliability, data integrity, and continuous inspection readiness.
  • Evaluate the effectiveness of individual equipment calibration strategies and collaborate with asset owners and Quality to implement risk-based improvements that enhance performance and compliance.
  • Serve as the technical lead for identifying, investigating, and resolving calibration and equipment performance deficiencies using structured root cause analysis and sound engineering judgment.
  • Initiate and actively participate in GMP investigations, deviations, CAPAs, and change control processes related to calibration, maintenance, and equipment performance.
  • Develop, maintain, and execute department self-audit programs for equipment repair and maintenance activities, including:
    1. Creating audit checklists
    2. Conducting audits
    3. Preparing reports
    4. Recommending and tracking corrective actions
  • Manage and forecast calibration-related budgets by tracking expenses, analyzing trends, and supporting annual maintenance cost planning.
  • Supervise and manage third-party service providers, including:
    1. Scheduling and coordinating services
    2. Escorting vendors in GMP and cleanroom environments
    3. Ensuring work is performed in accordance with US WorldMeds EHS, GMP, and quality requirements
    4. Verifying documentation is complete, accurate, and recorded at the time of service
  • Align calibration and maintenance activities with manufacturing schedules to ensure work is completed before due dates while minimizing production impact.
  • Independently review and analyze equipment history, trends, and performance data to identify reliability risks and recommend improvements to calibration and maintenance strategies.
  • Identify, procure, and maintain inventories of critical spare parts, calibration standards, and standby equipment necessary to support maximum operational capacity and system reliability.
  • Respond to equipment, building, and utility alarms after hours on a rotational basis, including acknowledging alarms through the BMS and supporting emergency troubleshooting and resolution.
  • Participate in the evaluation of Facilities-related process gaps and contribute to cross-functional efforts to close compliance, efficiency, and reliability gaps.
  • Research industry best practices, engage in professional networking, and apply technical expertise to develop and recommend commercial-level calibration and maintenance process improvements.
  • Assess the effectiveness of implemented improvements and report findings, trends, and recommendations to asset owners and leadership.
  • Ensure all calibration records are organized, complete, accurate, and maintained in strict accordance with GDP requirements.
  • Perform all activities in compliance with applicable cGMP regulations and relevant FDA, USP, and ISPE guidelines.
  • Champion GMP compliance, data integrity, and maintenance best practices to support a best-in-class calibration and reliability program.
  • Develop, revise, and maintain SOPs, work instructions, and technical documentation related to calibration and maintenance processes.
  • Serve as the internal audit lead for Facilities processes related to equipment maintenance and calibration, including gap analysis, documentation of findings, and recommendations for corrective actions.
  • Provide technical mentorship and guidance to junior engineers, technicians, and cross-functional partners as needed.
  • Perform additional duties and special projects as assigned in support of a rapidly growing and evolving organization.

QUALIFICATIONS:

  • Bachelor's degree in Engineering required with 7-10+ years of experience in pharmaceutical or biotech manufacturing, including process equipment support, calibration, and GMP compliance. Advanced degree preferred.
  • Demonstrated commitment to precision, accuracy, and high-quality workmanship in all technical and compliance-related activities.
  • Strong written and verbal communication skills with a proven ability to work effectively in highly collaborative, team-based environments.
  • Excellent analytical, troubleshooting, and critical-thinking skills, with hands-on experience diagnosing and resolving equipment and utility performance issues.
  • Proven ability to partner effectively with both technical and non-technical stakeholders across all levels of the organization.
  • High-energy, results-oriented professional with a confident yet approachable demeanor and a strong bias for action.
  • Availability to participate in a scheduled rotational on-call program to respond to after-hours equipment and utility emergencies.
  • Experience using computerized maintenance management systems (CMMS), such as Blue Mountain or equivalent platforms.
  • This role is fully on-site, requiring five days per week in-office presence.
  • Formal training and/or certification in metrology are strongly preferred.
  • Experience within the biopharmaceutical or pharmaceutical manufacturing industry.
  • Hands-on calibration experience across a broad range of process equipment and utility systems in a GMP-regulated manufacturing environment.
  • Working knowledge of GMP Quality Management Systems, including deviations, investigations, CAPAs, and change controls.
  • Strong ability to analyze raw calibration and performance data, interpret results, and determine appropriate corrective actions.
  • Proven ability to consistently apply standardized work methods with a high level of precision to ensure data integrity and quality outcomes.
  • Experience completing and maintaining GMP-compliant documentation related to calibration, maintenance, and equipment activities.
  • Demonstrated ability to organize and manage calibration schedules using Excel, CMMS, or other electronic tools to ensure all work is completed within required due dates.
  • Exceptional organizational skills and adaptability, with the resilience to manage conflicting priorities and rapidly changing schedules.
  • Ability to work independently with minimal supervision while also thriving in a collaborative team environment.
  • Experience working in and gowning for GMP cleanroom environments.
  • Highly collaborative mindset with strong alignment to business objectives, organizational values, and strategic priorities.
  • Prior experience supporting complex biotechnology and/or pharmaceutical manufacturing operations.
  • Working knowledge of AutoCAD or similar engineering drawing software preferred.

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 organization's 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 organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
  • Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
  • Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
  • Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
  • Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

PHYSICAL DEMANDS:

  • Frequently required to stand
  • Frequently required to walk.
  • Frequently required to sit.
  • Frequently required to talk or hear.
  • Occasionally required to lift light weights (less than 30 pounds)
  • Specific vision abilities required for this job include: close vision, color vision and ability to adjust or focus

WORK ENVIRONMENT:

  • The noise level in the work environment usually is quiet.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

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