As a Senior HVAC Maintenance Technician, you will lead preventive/predictive/corrective maintenance across various systems, ensuring cleanroom compliance with ISO 14644 standards.

Key responsibilities include:

• Optimizing and troubleshooting BMS/EMS/SCADA systems from Siemens, Allen-Bradley, and Johnson Controls
• Coordinating calibration and supporting IQ/OQ/PQ with solid validation documentation
• Driving investigations and CAPA using RCA methods
• Maintaining impeccable cGMP/GDP records and SOPs
• Championing audit readiness and keeping systems in a validated state

To succeed in this role, you will need:

• A technical diploma or apprenticeship in HVAC/Mechanical/Building Services, or a bachelor's degree in Mechanical/Building
• 6-10 years of experience in HVAC maintenance, including 3-5 years in pharma/biotech or regulated GMP environments
• Strong technical strengths in AHUs, chillers, boilers, hydronics, and humidity control
• GMP know-how, including ISO cleanroom classifications and aseptic requirements
• Validation experience, including sensor calibration and IQ/OQ/PQ

In return, you can expect:

• An annual base pay ranging from $71,749.60 to $107,624.40
• Eligibility for various incentives, including short-term incentive bonuses and equity-based awards
• Benefits, including qualified retirement programs, paid time off, and health, dental, and vision coverage

If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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In this role, you will collaborate with cross-functional and cross-regional teams to implement and maintain Quality Management Systems (QMS) across diverse R&D and operational locations. You will apply quality methodologies and tools such as Six Sigma, Lean, and CAPA to identify improvement opportunities, standardize best practices, and reduce variability in processes.

Responsibilities:

• Collaborate with cross-functional and cross-regional teams to implement and maintain Quality Management Systems (QMS) across diverse R&D and operational locations
• Apply quality methodologies and tools to identify improvement opportunities, standardize best practices, and reduce variability in processes
• Support and conduct quality audits and assessments to ensure adherence to internal quality standards, SOPs, and applicable regulatory requirements
• Provide training, coaching, and day-to-day support to team members on quality processes, tools, and methodologies
• Analyze quality data and metrics to identify trends, root causes, and systemic issues, and translate insights into actionable improvement plans
• Develop, maintain, and continuously improve quality documentation, including standard operating procedures (SOPs), work instructions, and quality plans
• Act as a liaison between R&D and operational teams, ensuring effective communication, alignment, and collaboration on quality-related initiatives and global quality projects
• Contribute to and help lead global quality initiatives and projects that shape the overall quality strategy of the R&D organization, ensuring consistency, transparency, and impact

Requirements:

• Bachelor's degree in a relevant field (e.g., Engineering, Quality Assurance, Life Sciences)
• Minimum of 5 years of experience in quality management, preferably within an R&D or manufacturing environment
• Strong knowledge of Quality Management Systems (QMS) and quality methodologies (e.g., ISO standards, Six Sigma, Lean), with hands-on experience applying these in operational settings
• Proven problem-solving skills and a proactive, data-driven approach to quality improvement, including experience using quality tools and software applications
• Excellent communication and interpersonal skills, with the ability to work effectively in a global, cross-functional team environment and influence without direct authority
• Demonstrated ability to manage multiple projects and priorities in a fast-paced environment, including project management experience and the ability to drive projects to completion under tight timelines
• Willingness and ability to travel independently up to 20%, including both domestic and international locations

Benefits:

• Competitive salary range: $91,000 - $141,000
• Bonus or incentive compensation (if relevant)
• Health care, vision, dental, retirement, PTO, sick leave, etc.
• Opportunity to work with a global team and contribute to the development of a leading life sciences company

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Key Responsibilities:

• Proactively track and monitor all Change and/or Deviation Management System and related compliance commitment activities/due dates for the Clinical Trial Labeling organization. Provide communication and follow up throughout the organization to help ensure on-time completion.

• Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve turn-around times for CAPA, deviations and changes.

• Create and enter observation records and change controls into Change/Deviation Management System.

• Work with Clinical Trial Labeling team members, including quality, to assist/support completion of deviations and changes that support improvements to current processes, while ensuring adherence to timelines.

• Create and maintain CAPA events and changes in Deviation Management System

• Leverage project management skills to develop plans for change-controls and events, ensuring pro-active communications and on-time completion of events and changes

• Develop and maintain CAPA expertise and Change/Deviation Management System knowledge

• Lead and assist in identifying root causes when issues occur and develop, recommend, communicate, and implement corrective actions and lessons learned

• Work across functional areas with individuals of all levels of the organization

• Collect and report metrics

Additional responsibilities may include:

• Identify root causes when issues occur and develop, recommend, communicate and implement corrective actions and lessons learned

• Effectively plan for upcoming work and communicate to other groups (e.g., outsourcing, ELECTS), as needed

• Collecting and reporting metrics

• Coaching and mentoring of other less senior Label Management Associates

Requirements:

• Bachelor’s degree or associate degree and 5+ years of healthcare/pharmaceutical experience

• Manage change controls and track progress throughout the lifecycle

• Multi-tasking (will likely be tracking multiple change controls/deviations for broader organization)

• High attention to detail

• Able to work with businesses to foster quality culture.

• Ability to work across functional areas with people of all levels of the organization.

• Strong oral and written communication skills.

• Ability to gather, edit, organize, and summarize information from multiple sources including databases, websites, site interviews, and audits.

• Strong working knowledge of Excel, Word, PowerPoint, Change/Deviation Management System (Trackwise and/or OneQMS or similar), and QualityDocs or similar EDMS programs

Preferred:

• Problem solver with strong self-motivation

• Effective written and verbal communication skills

• High initiative, flexible and positive attitude

• Interpersonal skills to work in cross-functional and multicultural teams

• Knowledge and experience working with QA in highly regulated area and relevant external experience, preferably within the industry, are highly beneficial.

• Previous root cause analysis experience

Benefits:

Keywords provides all its contingent workforce with:

• Medical, dental and vision benefits

• Paid time off (including sick and select holidays)

• 401(k) enrollment with 3% employer matching

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

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