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Contamination Control Jobs in Indiana (NOW HIRING)

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Cleanroom & Environmental Control: * Oversee maintenance of cleanroom environments, HVAC, and environmental monitoring systems to ensure compliance with contamination control protocols. * Train staff ...

Maintain oversight of cleanroom operations, including gowning, trafficking, cleaning, environmental monitoring, and contamination control. * Quality Systems Management Manage and support quality ...

Maintain oversight of cleanroom operations, including gowning, trafficking, cleaning, environmental monitoring, and contamination control. * Quality Systems Management Manage and support quality ...

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Contamination Control information

What are the key skills and qualifications needed to thrive in Contamination Control, and why are they important?

To thrive in Contamination Control, you need a solid understanding of cleanroom protocols, contamination prevention techniques, and relevant scientific or technical education, often with a background in microbiology or engineering. Familiarity with industry standards such as ISO 14644, environmental monitoring systems, and specialized cleaning equipment is typically required. Attention to detail, analytical thinking, and strong communication skills help professionals identify risks and collaborate effectively with cross-functional teams. These skills are crucial to maintaining regulatory compliance and ensuring product safety in sensitive environments like pharmaceuticals, electronics, or healthcare.

What are common challenges faced in a Contamination Control role, and how can they be addressed?

Professionals in Contamination Control often encounter challenges such as maintaining strict cleanliness standards, ensuring compliance with evolving regulatory requirements, and managing cross-departmental communication. These challenges can be addressed by staying updated on industry best practices, participating in regular training, and fostering a culture of accountability within the team. Collaboration with production, quality assurance, and facilities teams is crucial to proactively identify and mitigate contamination risks, helping to ensure a safe and compliant work environment.

What is contamination control?

Contamination control refers to the practices and procedures used to prevent, reduce, or eliminate the presence of unwanted substances (such as dust, microbes, chemicals, or particles) in controlled environments like laboratories, manufacturing facilities, or cleanrooms. These measures are crucial in industries such as pharmaceuticals, electronics, and food production to ensure product quality and safety. Techniques include the use of specialized equipment, protective clothing, air filtration systems, and strict cleaning protocols. Effective contamination control helps prevent product defects, health hazards, and regulatory non-compliance.

What is the difference between Contamination Control vs Cleanroom Technician?

AspectContamination ControlCleanroom Technician
CertificationsISO certifications, contamination control trainingCleanroom operation training, ISO standards
Work EnvironmentManufacturing, pharmaceutical, biotech cleanroomsCleanroom facilities in pharma, electronics, biotech
Employer & Industry UsageQuality assurance, contamination prevention teamsOperational staff maintaining cleanroom standards

Contamination Control focuses on preventing and managing contamination risks across various environments, often involving protocols, inspections, and training. Cleanroom Technicians operate within cleanrooms, executing specific procedures to maintain cleanliness standards. While both roles require similar certifications and work in related environments, Contamination Control has a broader scope, emphasizing contamination prevention strategies, whereas Cleanroom Technicians focus on daily operational tasks within cleanrooms.

What job categories do people searching Contamination Control jobs in Indiana look for? The top searched job categories for Contamination Control jobs in Indiana are:
What cities in Indiana are hiring for Contamination Control jobs? Cities in Indiana with the most Contamination Control job openings:
Infographic showing various Contamination Control job openings in Indiana as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Sr Manager Quality, Contamination Control Strategy Lead

Simtra BioPharma Solutions

Bloomington, IN โ€ข On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 27 days ago


Job description

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.
While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.
Why join Team Simtra?Because we:
Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.
The role:
The Sr Manager Quality, Contamination Control Strategy Lead is responsible for establishing, maintaining, and continuously improving the contamination control strategy at a sterile injectable manufacturing facility. He/she needs to drive compliance with regulatory requirements (FDA, EMA, PIC/S, Annex 1) and contamination control initiatives, microbiological oversight collaboration, and aseptic assurance across the manufacturing site. This role serves as the SME (subject matter expert) for aseptic practices, maintenance of aseptic observation program data metrics, and the overall contamination control strategy (CCS).
The Sr Quality Manager is expected to contribute to an environment where teamwork and productivity are encouraged, and safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. In addition, the Sr Quality Manager is expected to partner with QALO and operations leadership, training leadership, and the Contamination Control Strategy Team.
The responsibilities:
  • Owns the aseptic observer program, including oversight of aseptic practices, cleanroom behavior, and gowning:
    1. Responsible for design and continuous improvement of the Aseptic Observer Program (aseptic manufacturing quality oversight)
    2. Organize collected data from Aseptic Observer Program, analyze trends, lead cross functional review meetings, and make necessary improvements with operations leadership based on observations
  • Leads the development and implementation of the Contamination Control Strategy (CCS) according to EU GMP Annex 1 and supports its governance in line with applicable regulatory requirements, organizing routine team meetings, annual updates of strategy document, and SME presentation of strategy for audits
  • Assist with microbiological and sterility risk assessments for changes, deviations, and CAPAs involving aseptic operations.
  • Serve as the SME during regulatory inspections and audits regarding aseptic processing, and contamination control.
  • Present aseptic observation program data to site and executive leadership in management review forums, including trending and improvements made
  • Collaborates with manufacturing, microbiology, and QC as the site steward of the Contamination Control Strategy (CCS), to ensure appropriate cleanroom qualification, media fill (process simulation), environmental monitoring, and glove/sleeve integrity programs.
  • Supports contamination control assessments related to qualification and validation of equipment, utilities, (e.g. HVAC, WFI) isolators, RABS, and cleaning / disinfection procedures.
  • Mentors and assists with training aseptic operators, and QA personnel in and contamination control. Responsible for Provide guidance on improvement and standardization of the QALO training program, including incorporation of industry and regulatory intelligence.
  • Participate as needed in investigation and resolution of aseptic failures, sterility test failures, EM excursions, adverse trends and related aseptic non-conformances
  • Review and approve GMP documents related to aseptic processing, (SOPs, protocols, reports, batch records).
  • Lead continuous improvement projects related to aseptic behavior, risk mitigation, and cleanroom operations.

The qualifications:
  • Education: Bachelors degree in Microbiology (preferred), Biology, Pharmacy, or related science.
  • Masters degree or higher in Microbiology or Pharmaceutical Sciences is preferred
  • Minimum of 8 years of direct experience in sterile pharmaceutical manufacturing or QC microbiology / QA roles, including at least 5 years in SME capacity related to contamination control.
  • Demonstrated leadership or cross-functional team experience in aseptic processing environments (e.g. controlled areas (specifically A/B, isolators, OPEN and CLOSED RABS systems).
  • Proven track record of successful regulatory inspection participation (FDA, EMA, or equivalent) as SME for contamination control topics
  • Strong knowledge of EU GMP Annex 1, 21 CFR parts 210/211, USP<71>, <85>, <1116>, <797>, <1207> and current industry best practices
  • Understanding of aseptic processing, data interpretation, aseptic filling processes and equipment strategies, CCS design, and Quality Risk management (ICH Q9).
  • Strong communication skills as the role is expected to interface with clients, regulatory agencies, and site leadership, and being able to make decisions.
  • Strong technical writing skills for strategy documents, assessments and investigations.
  • Strong attention-to-detail, decision-making capability, and problem-solving in complex technical environments
  • Ability to train, mentor, and coach staff in aseptic technique and contamination control.

Working conditions:
  • Role requires frequent presence in Grade A/B aseptic environments; gowning certification is required.
  • May require occasional off-shift, off-hours, support during media fills, regulatory inspections, or critical interventions

In return, you'll be eligible for[1]:
  • Day One Benefits
    • Medical & Dental Coverage
    • Flexible Spending Accounts
    • Life and AD&D Insurance
    • Supplemental Life Insurance
      • Spouse Life Insurance
      • Child Life Insurance
    • 401(k) Retirement Savings Plan with Company Match
    • Time Off Program
      • Paid Holidays
      • Paid Time Off
      • Paid Parental Leave and more
    • Adoption Reimbursement Program
    • Education Assistance Program
    • Employee Assistance Program
    • Community and Volunteer Service Program
    • Employee Ownership Plan
  • Additional Benefits
    • Short and Long-Term Disability Insurance
    • Voluntary Insurance Benefits
      • Vision Coverage
      • Accident
      • Critical Illness
      • Hospital Indemnity Insurance
      • Identity Theft Protection
      • Legal and more
    • Onsite Campus Amenities
      • Workout Facility
      • Cafeteria
      • Credit Union

[1] Current benefit offerings are in effect through 12/31/26
Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.
Equal Employment Opportunity
Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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