Specialist Manufacturing Environmental and Contamination Control

Responsibilities

• Technical Ownership of Microbial Investigations
• Provide functional SME oversight for microbial events, including: Environmental Monitoring (EM) excursions, Bioburden / endotoxin / contamination signals
• Ensure investigations are scientifically sound and microbiologically justified
• Ensure true root cause identification with supporting data and rationale
• Accountability for Investigation Quality & CAPA
• Ensure: Thorough root cause analysis (RCA), Appropriate Corrective / Preventive Actions (CA/PA/EV) to prevent recurrence, Validate that: Each root cause has a corresponding action, CAPAs are effective, risk-based, and sustainable
• Decision Authority Product & Process Risk
• Accountable for: Decision and documented rationale for continued processing or disposition
• Collaborate with QA to ensure: Decisions are defensible, risk-appropriate, and aligned with GMP expectations
• Deviation Classification & Designation
• Support Contribute to Major vs Minor classification decisions based on impact and controls
• Ensure classification reflects true microbiological risk (not convenience or precedent)
• Resource & Investigation Oversight
• Ensure: Appropriate SME engagement (e.g., Microbiology, QC, MFG), Adequate resources are deployed to support investigation depth, Cross-Functional Integration (Critical for Microbial Events)
• Work closely with: QC Microbiology (EM data interpretation), Manufacturing (aseptic behavior, execution), QA (final decision authority)
• Embedded within ECC model with dedicated microbial expertise and deviation FAO support
• Own the ECC genba program and ensure cross-functional participation, effective engagement, and actionable outcomes
• Engagement Across Deviation Lifecycle
• Maintain active involvement from triage through closure
• Ensure: Timely decisions, Strong documentation, Alignment across stakeholders, Inspection Readiness & Defense
• Act as key spokesperson during inspections for microbial events
• Must: Clearly articulate root cause, Defend classification rationale, Demonstrate CAPA effectiveness
• Key Differentiators Microbial FAO vs Standard FAO
• Demonstrate Microbial science depth

  Qualifications

  • High school diploma/GED and 10 years of directly related experience OR Associates degree and 8 years of directly related experience OR Bachelors degree and 4 years of directly related experience OR Masters degree and 2 years of directly related experience OR Doctorate degree
  • Preferred Qualifications
  • The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent BS/BA or equivalent (Microbiology/Life Science) 8+ years of Microbiology industry experience in the pharmaceutical industry
  • Experience applying AI or other digital tools to generate insights and streamline workflows
  • Strong understanding of GxP and deviation management processes and Microbiology / contamination control principles
  • Able to apply risk-based decision making, influence cross-functional teams & communicate clearly under inspection pressure
  • Strong understanding of EM program design and limitations, objectionable organisms & contamination pathways and aseptic processing risk
  • Knowledge of network and industry trends in managing and responding to microbial contamination risk

  What You Can Expect From Us

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

  Additional Information

  • Application deadline: Not specified
  • Sponsorship: Not guaranteed
  • Equal Opportunity Employer
  • Redacted information may be removed from any materials submitted