Senior Manager, Sterile Processing Job at STERIS (Chicago)

Sterile Processing Tech II

Assembles instrument trays for surgical procedures using computerized count shee...

Location

United States , Needham

Salary:

22.35 - 35.76 USD / Hour

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

High School Diploma/GED required
Minimum of two years of experience in Sterile Processing required
Certified Registered Central Service Technician (CRCST) OR certified Sterile Processing and Distribution Technician (CSPDT) required

Job Responsibility

Transports and restocks surgical instrumentation and medical materials within surgical suites and SPD according to departmental policies
Receives, sorts, cleans, and decontaminates soiled reusable instruments and equipment, manually logging items received
Operates and maintains cleaning and decontamination equipment such as washers, reprocessors, and pasteurizers
Inspects, prepares, assembles, and sterilizes surgical instruments and materials, following standardized lists and manufacturer guidelines
Loads, programs, and monitors sterilizers during sterilization cycles to ensure proper operation and safety
Manages telephone communications, providing routine information and directing complex inquiries to supervisors
Provides departmental leadership in the absence of senior staff, organizing daily operations and prioritizing work to meet clinical needs
Addresses customer requests, resolves issues, and completes daily shift reports to maintain smooth department workflow

What we offer

$8,500 sign on bonus for full-time hires
flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Senior QA Executive 1

You will play a key role in ensuring quality and compliance in a modern manufact...

Location

Singapore , Tuas

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science, microbiology, biotechnology, pharmacy, engineering, or a related discipline
At least 6 years of experience in quality assurance within the pharmaceutical or biologics industry
Strong knowledge of GMP and regulatory requirements relevant to manufacturing and quality
Practical experience with deviations and CAPA processes
Experience with validation, qualification and change control practices
Good written and verbal communication skills in English

Job Responsibility

Provide QA oversight - Sterility Assurance for site manufacturing processes and products manufactured by the site
Provide QA oversight – Quality control laboratory for Microbiology and Endotoxin tests
Develop, implement, and monitor sterility assurance programme on site
Lead sterility assurance activities: sterile process oversight, container closure integrity (CCI) strategies, aseptic process simulation (media fills), and bioburden or sterility-related investigations
Develop, review and approve microbiology and sterility-related SOPs, specifications, and test methods
ensure documentation is current and GxP-compliant
Provide technical direction for microbiology method development, transfer, validation, troubleshooting, root cause analysis, and corrective/preventive actions (CAPA)
Manage deviations, OOS/OOT events and non-conformances related to microbiology and sterility
lead investigations and ensure timely regulatory-compliant reporting
Establish and maintain environmental monitoring programmes

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Sterility Assurance Scientist

This technical role is responsible for developing and implementing the site’s st...

Location

United States , Concord

Salary:

35.00 USD / Hour

Medasource

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or related scientific discipline
Demonstrated understanding and experience with scientific principles for manufacturing parenteral drug products under cGMP conditions, including operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance
2+ years (Senior) or 5+ years (Principal) pharmaceutical manufacturing experience in microbiology, sterility assurance, TSMS, or related departments
Technical expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, cleaning/sanitization strategies, and disinfectant efficacy
Knowledge of microbiological media, enumeration techniques, and microorganism isolation and identification (Principal level)
Strong interpersonal, organizational, oral, and written communication skills for cross-functional teamwork and technical documentation
Experience with data analysis, trending, and root cause investigations related to sterility assurance programs
Ability to wear appropriate PPE and gown into cleanroom attire as required for manufacturing or laboratory environments
Flexibility to support varying production schedules, including occasional extended or off-hour work and travel for training and implementation
Ability to perform tasks requiring repetitive motion, standing or walking for long periods

Job Responsibility

Develop and implement sterility assurance programs and contamination control strategies for the site
Provide technical guidance and oversight for environmental monitoring, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization activities, including disinfectant efficacy
Lead or support technical activities related to airflow pattern testing, environmental monitoring performance qualifications (EM PQ), aseptic processing techniques, and facility monitoring
Author, execute, review, and approve technical documents, protocols, and change controls related to sterility assurance programs
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvement
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls for potential microbial, endotoxin, and particulate contamination
Lead or support root cause investigations and corrective actions for sterility assurance issues
Participate in and provide technical support during internal and external audits
Mentor team members and collaborate with cross-functional teams to achieve business and quality objectives
Support the development and maintenance of cleanroom gowning and aseptic technique strategies/programs

What we offer

Competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
401k plan that includes a company match and is fully vested after you become eligible
Paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Senior Manager Validation

Reporting to the Associate Director of Validation, the Senior Manager of Validat...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Typically 8+ years of experience in management position
Typically 4+ years' experience supervising validation / technical staff
Graduate degree in Science (Microbiology, Cell Biology, Biochemistry an advantage) or Engineering
Significant experience working in a GMP environment within the pharmaceutical/biotechnology industry in the areas of process, plant, equipment, cleaning, analytical methods and computer systems validation
Detailed knowledge of the regulatory requirements across a range of geographies but particularly the US, EU, Canada, Australia and Japan
Substantial experience within the biotechnology sector, with prior experience in the areas of sterile liquid filling, packaging and labelling an advantage

Job Responsibility

Lead in the development of Validation’s vision, mission, strategies, goals and objectives
Maintain, implement and continuously develop a Validation strategy
Responsible for providing Validation expertise in area of equipment sterility, aseptic processing simulation (or media fill) and temperature mapping
Manage the qualification/validation of production equipment, utilities and systems directly associated with sterility of equipment and processes
Provide support for Tech Transfers (NPIs and LCMs) and regulatory submissions
Oversee the preparation, execution, documentation and reporting of validation studies
Responsible for the development, revision, review, and approval of Standard Operating Procedures
Strong people and project management skills with proven ability to define and execute the validation elements of a projects from design to routine facility operation
Capable of creating a team environment among existing site groups and creating a unified culture within the validation organization
Assure the appropriate level of training is undertaken for all levels of the validation organization

Fulltime

Head of technical operations

Mantell Associates is partnered with a leading global CDMO, who is seeking a sea...

Location

Germany , Hamburg

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Deep experience having worked in a CDMO environment, ideally leading technical operations or similar senior operational roles for drug product manufacturing
Strong background in drug product (finished dosage forms – sterile or non-sterile) manufacturing operations, process development, and scale-up
Excellent technical, scientific, and engineering problem-solving skills
able to lead tech transfer, manufacturing troubleshooting, equipment qualification/validation, and process optimization
Fluent in German (spoken and written) to lead teams locally and interact with global stakeholders
Demonstrated leadership experience managing sizeable technical/operations teams, driving operational metrics, and ensuring throughput, quality, GMP compliance, and cost performance
Based in or able to relocate to Hamburg, Germany, with willingness for hybrid on-site presence

Job Responsibility

Lead and direct the Technical Operations department overseeing drug product manufacturing, including process development, scale-up, technology transfer, formulation operations, and GMP production
Provide technical leadership and mentorship to cross-functional teams (Manufacturing, Process Engineering, Quality, MSAT) and ensure alignment of technical strategy with production capabilities
Drive continuous improvement of processes, yield, cost of goods, throughput, and capacity utilization by implementing robust process optimization and lean manufacturing principles
Ensure reliable execution of technology transfers to/from Hamburg site, enabling smooth handoffs from R&D / development labs into GMP manufacturing
Oversee technical troubleshooting, deviations, and root cause investigations
proactively address performance bottlenecks, equipment or facility constraints, and process drift
Maintain regulatory and GMP compliance (EU GMP, EMA, German regulatory bodies) in all operational and technical activities
ensure site readiness for audits and inspections
Collaborate closely with Supply Chain, Quality Assurance, Regulatory Affairs, and Commercial teams to support product launch readiness and client commitments

Fulltime

Project Engineer II

This position is responsible for the management and execution of multiple and si...

Location

United States , Birmingham

Salary:

Not provided

Evonik Industries

Expiration Date

Until further notice

Requirements

MS/BS in an engineering or scientific field with a minimum of 3-5 years of project management experience with a well demonstrated level of performance and capability in the completion of large CAPEX projects for internal and external customers up to $5M
Demonstrated experience in developing accurate and well defined project scopes, deliverables, cost estimates, and timelines and successfully executing against those items across multiple simultaneous on-going projects
Understanding of different engineering project phases (conceptual, basic and detailed engineering) is required, including the different scopes, requirements, deliverables and timelines associated with each phase
Knowledge of relevant engineering principles and theories as well as the capability to use and apply standard engineering procedures and techniques, especially in the field of pharmaceutical process and equipment design and specifications, as well as pharmaceutical facility buildouts and expansion (cleanrooms, utilities)
Strong knowledge of fields related to pharmaceutical product development process and multiple drug delivery technologies that includes sterile manufacturing, high potent API manufacturing, filling, lyophilization, sterilization (SIP) and cleaning (CIP)
Demonstrated project engineering experience with facility infrastructure type projects with a strong emphasis on civil and mechanical disciplines for designing and executing facility cleanroom/laboratory buildouts, and pharmaceutical grade utility systems (HVAC, WFI, steam, compressed air, nitrogen, boilers, electrical systems)
Demonstrated experience with leading and participating in ESH safety analysis and reviews such as HAZIDs and PHAs and implementing proper safety designs into projects
Strong knowledge of pharmaceutical standards and guidelines for process and equipment requirements based on FDA, ISPE and BPE guidelines for cGMP operations and CSV, CFR 21 compliance for electronic systems
Strong knowledge and understanding of QMS processes and procedures utilized at the BHM Labs site
Experience with process and equipment qualification such as FATs, SATs, commissioning, IOQs is required

Job Responsibility

Plan, coordinate, and execute assigned projects by effectively using Project Management methodologies (such as MS Project) from conceptual design to financial close for projects up to $5M
Acts as the Engineering Lead for assigned projects and assembles a cross-functional team to drive the engineering activities
Develops project scopes that include complex process designs, project plans, and project deliverables
Identifies equipment lists and specifications with suppliers, creates engineering drawings (PFDs, P&IDs, general arrangement), and specifies facility requirements or modifications to meet the project deliverables
Builds well defined cost estimates and timelines for the project scope
Manages project related procurement processes from initial quoting to final invoicing
Collaborates with Evonik Safety to execute risk and hazard analysis associated with projects and implement any mitigating safety requirements
Performs costs analysis and review alternative project designs to implement best business solutions that optimize costs and functionality
Coordinates and executes all required QMS processes and procedures related to engineering projects
Communicates general project status including cost and timeline forecasts to the client and other project stake holders

What we offer

performance-based remuneration
occupational health benefits
hybrid and flexible working environments with #SmartWork
attractive career paths
high-quality development programs

Fulltime

Director, Validation

As a member of the Validation organization, the Validation Director will lead ph...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science or engineering required
15+ years of progressive leadership of operational validation experience in Pharmaceutical or Biotechnology industry, required
Sound industry knowledge of pharmaceutical and medical device facilities, lyophilization technology, cleanrooms, facilities clean utilities. WFI, purified water, process gasses, HVAC and industry processes and utilities
Experience in successful management of complex technical issues using structured analysis, methodology and articulates clear and concise direction to other operations staff
Strong experience with project and people management, particularly for large validation projects or programs
Experience in Facility, Equipment and Utility or Cleaning validation is a must (preferably in a multi-product CMO facility)
Demonstrate SME level knowledge of process/equipment validation, computer systems, standards and GxP regulations. Strong technical experience in the successful management of complex validation is required
Able to effectively lead and coordinate multiple, complex requests/projects and allocate resources effectively, across multiple sites, managing both local and remote based staff
Advanced understanding of applicable regulatory requirements (FDA, EMA, international regulatory)
Advanced understanding of industry standards for commissioning and validation of facilities, utilities and process equipment for cGMP manufacturing

Job Responsibility

Provide strategic and operational leadership to the Validation function, ensuring continuous, compliant execution of validation activities in alignment with established procedures, schedules, and business objectives
Evaluate process, equipment, and systems validation capabilities across Operations and develop short- and long-term improvement strategies to support corporate and regulatory goals
Guide the strategy for development, execution, review, and approval of all validation documentation, including IQ, OQ, and PQ protocols and reports
Ensure effective oversight of change control, deviations, investigations, and CAPAs related to validation activities
provide leadership in Quality Management System (QMS) integration and inspection readiness
Partner with senior leadership to define and implement validation strategies for new and existing processes, equipment, utilities, and systems, translating strategy into compliant protocols and SOPs
Direct and manage all aseptic and non-aseptic validation activities, including process validation, cleaning validation, sterilization validation, and equipment qualification
Maintain ownership and accountability for the site Master Validation Plan, ensuring alignment with regulatory expectations and business needs
Serve as a primary client and internal stakeholder interface for assigned validation projects, ensuring alignment on scope, timelines, and compliance requirements
Provide strategic leadership for validation-related regulatory inspections and third-party audits, including timely and effective closure of observations and commitments

Fulltime

Senior Director, Manufacturing, Science & Technology

As a Senior Director, Manufacturing, Science & Technology, you will lead a high-...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

PhD in Chemistry, Biochemical Engineering, or a related scientific discipline
Extensive experience in pharmaceutical or biotechnology manufacturing, with deep expertise in process development for both small and large molecules
Proven knowledge in sterile processing, fill-finish operations, and packaging
Strong understanding of CMC requirements and regulatory dossier submissions (EMA, FDA)
Inspirational leadership with a hands-on approach to managing technical operations, complex projects, and cross-functional teams
Exceptional analytical, scientific, and communication skills, with the ability to convey complex concepts to diverse stakeholders
Fluency in English is essential
Willingness to travel internationally as required

Job Responsibility

Provide strategic direction and technical oversight for all external manufacturing activities
Lead and oversee the execution of technology transfers, validation programs, and lifecycle management for both new and existing products
Establish and monitor performance metrics, proactively manage risks, and make data-driven decisions aligned with business objectives
Ensure robust technical evaluations for material changes, process scale adjustments, and cost-efficiency initiatives
Contribute to vendor qualification, audit processes, and long-term capacity and supply planning
Ensure full compliance with cGMP regulations and internal quality standards across all operations
Lead and manage a team of pharmaceutical technical and scientific experts
Serve as the primary technical liaison with CMOs, ensuring alignment with strategic goals and regulatory expectations

What we offer

A fast-paced environment, with broad exposure, where you can develop professionally – even outside your area of expertise
We support you as you grow and learn, and we love to celebrate success and recognize performance
We provide opportunities for driven and talented professionals who want to be part of our exciting journey

Senior Manager, Sterile Processing

STERIS

Location:
United States , Chicago

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 30, 2026

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