Technical Manager – Bridges and Civil Structures
AtkinsRéalis
Senior Manager, Validation and Aseptic Processing
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Office
Location: Miami • Florida, New York • 🇺🇸 United States
Visit company websiteSalary
💰 $118,100 - $177,200 per year
Job Level
Senior
About the role
- Assess, lead, and continually improve the aseptic process/behavior program to ensure robust contamination control and GMP compliance
- Lead the Quality review and approval of validation documents, ensuring alignment to regulatory expectations
- Conduct internal audits in the area of validation requirements, seeking opportunities for systemic improvement
- Establish and maintain a standardized aseptic behavior framework, including procedures, training, observations, and metrics across all sites
- Perform periodic risk assessments of aseptic operations; implement mitigation strategies, and verify effectiveness
- Lead gemba/behavioral observation programs and manage/report key performance metrics to leadership
- Own QA oversight for process, cleaning, equipment, utilities, computerized systems, etc.
- Approve validation and qualification outputs; ensure documented rationale, statistical adequacy, and data integrity
- Harmonize validation standards, templates, and practices; drive cross-site consistency and change control governance
- Partner with Operations, Engineering, MSAT, and QC on tech transfers, change controls, deviations, and investigations with validation impact
- Review regulatory trends; update policies/SOPs and training to maintain compliance
- Lead a matrixed cross-site team; provide mentoring, workload prioritization, and competency development in validation and aseptic practices
Requirements
- Bachelor’s or Master’s in a science/engineering field; advanced degree preferred
- 5+ years in GMP environments with strong validation and aseptic manufacturing experience; multi-site experience preferred
- Demonstrated expertise in validation lifecycle management, aseptic behavior programs, internal auditing, and CAPA leadership
- Strong knowledge of applicable regulations and standards
- Excellent communication, influence, and ability to independently lead project teams
- Good understanding of statistical techniques; six sigma certification is a plus
Benefits
- Healthcare
- Annual incentive plan bonus
- Employee assistance and family support programs
- Commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO)
- 10 paid holidays annually
- Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
- Accident and life insurance
- Short- and long-term disability
- Retirement and savings programs, such as our competitive 401(k)
- Employees’ Stock Purchase Plan (ESPP)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
aseptic processGMP compliancevalidation lifecycle managementinternal auditingCAPA leadershipstatistical techniquesrisk assessmentschange control governancetech transfersdata integrity
Soft skills
communicationinfluenceleadershipmentoringworkload prioritizationcompetency developmentsystemic improvementcollaborationproblem-solvingindependent project leadership
Certifications
six sigma certification
