Environmental Monitoring Program Lead Consultant

ProPharma; United States; Remote; USD 96,000 - 165,000; Full time

Job summary

ProPharma, located in Kansas City, KS, is seeking a senior consultant to lead environmental monitoring and contamination control initiatives for a 3-month engagement onsite. The role demands in-depth experience in environmental monitoring, microbiology, and sterile manufacturing processes.

Key responsibilities include directing EM procedures, investigations, sampling strategies, and risk assessments, along with maintaining cleaning and disinfection standards in line with industry regulations.

Qualifications

• Experience in environmental monitoring programs in sterile manufacturing.
• Knowledge of microbiology concepts and aseptic processing.
• Hands-on contamination control and aseptic cleanliness practices.
• Experience with cleaning and disinfection validation protocols.
• Familiarity with Annex 1 and regulatory expectations.

Responsibilities

• Lead assessment of EM and contamination control programs onsite.
• Develop and implement EM procedures, investigations, and trending.
• Design sampling strategies and conduct risk assessments.
• Oversee cleaning/disinfection practices to maintain sterility.
• Collaborate with client teams and ensure regulatory alignment.

Skills

Environmental monitoring

Microbiology

Contamination control

Cleaning/disinfection

Annex 1

Job description

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Location: Kansas City, KS (onsite) Duration: 3 months Scope: This consulting role will lead the assessment of the environmental monitoring and contamination control program, including EM procedures, investigations, trending, sampling strategies, cleaning and disinfection practices, and associated risk assessments. Years of Experience: 10 years

Key Experience Required:

• Environmental monitoring
• Microbiology
• Contamination control
• Cleaning/disinfection
• Annex 1
• Sterile manufacturing #LI-JH1 #LI-HYBRID

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.