Clean Room Environmental Monitoring Supervisor at Cambrex in Marlborough, Massachusetts

Job Description:

Cambrex


Clean Room Environmental Monitoring Supervisor

US-MA-Marlborough

Job ID: 2025-4228
Type: Regular Full-Time
# of Openings: 1
Category: Clean Room Services
Cambrex

Overview

The Clean Room Environmental Monitoring Supervisor is responsible for the daily operations of the Cleanroom Services analysts based in Marlborough, MA. This role may be classified as a Supervisor or Associate Manager depending on leadership experience. This role provides technical leadership for the team in a CDMO environment.  In this role, you will be responsible for the supervision of hourly employees in order to meet the safety, environmental, compliance, quality, productivity, as well as to meet customer delivery dates. As the Location Leader, you will provide direction and leadership for your assigned team in the areas of safety, quality, productivity and engagement to ensure goals are met. 

 

This position is also responsible for overseeing employee training, enforcing all rules, policies and procedures, recommending and applying disciplinary action when required, verifying work hours in timecards.

 

This role ensures that all CRS activities are in compliance with company SOPs, GMP/GLP standards and FDA/EU and ISO 17025 regulations. Analyzes information for accuracy and compliance to internal procedure, CGMP and other regulatory guidelines.

Responsibilities

• Oversee the day-to-day operations of the Cleanroom Services Department.
• Collaborate with CRS leadership team to create daily schedules
• Lead team huddles to ensure effective communication, planning and resource use
• Regularly inspect work to ensure consistency in the quality and pace of work
• Ensure all work is completed in a timely manner by trained team members following written procedures in a cGMP compliant environment.
• Delegate projects and follow up to ensure effective delegation, with objectives met on time and within budget
• Ensure that the Cleanroom Services Department is maintained in an audit ready state: Perform audit for accuracy and completeness, oversight of training, audit technical documents (e.g. reports, protocols, test procedures, SOPs, etc.), oversight of compendial method verifications and method transfers, and manage quality events.
• Audit schedules to ensure that training, BMRAM, Master Control, Quality Event and other tasks are included
• Use checklists and system reports to ensure compliance
• Represent Cleanroom Services Department interests in meetings, collaborate and cooperate to achieve cross-functional improvements and business goals
• Support cross-training, resource sharing and diverse career paths
• Create departmental systems, departmental monitors, and foster a culture of continuous improvement focused on value to the customer
• Improve the consistency and predictability of quality, pace and cost of the Cleanroom Services Department. Create flowcharts and optimize the sequence of processes and systems. Eliminate waste and create flow.
• Assist with creation of budgets, forecasts, plans, models, and business cases to support projects to improve quality, pace, profitability, and growth. Review and approve expenditures within allocated budgets.
• Assist with selecting team members. Partner with HR to:
• Recruit, develop and promote talent, providing regular feedback for team members.
• Discipline and terminate team members that do not meet expectations.

 

Qualifications

• High school diploma or Associate’s degree required.
• Bachelor’s degree in Chemistry or Microbiology or other Life Sciences degree preferred.
• 3+ years of experience in a regulated industry with at least one year of related experience leading / managing employees, preferred. At the Associate Manager level at least 2+ years leadership experience is required.
• Experience supporting medical device and pharmaceutical manufacturing.
• Experience performing root cause analysis

 

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.    

 

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Equal employment opportunity, including veterans and individuals with disabilities.

PI267020665

Salary:

$60,742.00

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