Microbiology Development Tech Job at MillenniumSoft Inc (El Paso)

Contamination Control Manager

This is a senior, high-impact role for a contamination control leader who combin...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master's preferred)
Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO
Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control
Proven experience leading FMEA and cross-functional risk assessments
Solid understanding of global regulatory expectations
Ability to influence in matrixed environments with strong communication, coaching and facilitation skills

Job Responsibility

Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations
Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes
Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development
Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction
Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness
Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers
Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends
Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement
Champion a strong site-wide contamination control culture where prevention is everyone's responsibility
Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations

What we offer

Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme

Fulltime

Contamination Control Manager

This is a senior, high-impact role for a contamination control leader who combin...

Location

United Kingdom , Falkirk

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Degree in Microbiology, Biology, Biochemistry, Chemical Engineering or related discipline (Master's preferred)
Extensive industry experience in sterile or biologics pharmaceutical manufacturing, ideally within a CDMO
Strong expertise in aseptic processing, cleanroom operations and microbiological contamination control
Proven experience leading FMEA and cross-functional risk assessments
Solid understanding of global regulatory expectations
Ability to influence in matrixed environments with strong communication, coaching and facilitation skills

Job Responsibility

Own and evolve the site Contamination Control Strategy in line with EU/UK GMP Annex 1, FDA and ICH expectations
Embed contamination control principles into facility and equipment design, process flows, cleaning and sterilisation strategies, supplier management and training programmes
Partner with Manufacturing to influence aseptic behaviours, shift routines, operator decision-making and capability development
Collaborate with MSAT across equipment design, tech transfer, scale-up, process characterisation and new product introduction
Ensure full integration of the CCS with Quality systems including deviations, investigations, CAPAs, change control and audit readiness
Lead contamination-focused risk assessments (including FMEA) across client processes, shared equipment, utilities, campaign manufacturing and changeovers
Translate risk into practical, executable operational controls and maintain assessments as living tools informed by data and trends
Design and deploy contamination control training tailored to a CDMO environment, reinforcing learning through hands-on coaching and on-the-floor engagement
Champion a strong site-wide contamination control culture where prevention is everyone's responsibility
Provide governance-level oversight of contamination-related data, driving continuous improvement and reduction of repeat deviations

What we offer

Excellent salary and benefits package including enhanced pension, healthcare and annual bonus scheme
A chance to make a real difference and lead from the front in a key role on site
Working at the forefront of the biologics industry

Fulltime

New

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality
Manages the Quality organization in a mid to large size plant
Manages the batch review and release activities
Fulfills the role of PRRC
Directs large programs and departments in support of division or company-wide initiatives
Develops and deploys the quality systems
Understands and deploys processes to assure conformance to regulations
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion. Manages the batch review and release activities
Fulfills the role of PRRC, specific to: Ensuring conformity of the devices is appropriately checked, in accordance with the Quality Management System, before release
Ensuring Post-Market Surveillance (PMS) obligations are met
Ensuring reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)
Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies
Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements
Understands and deploys processes to assure conformance to regulations in a mid-to-large plant or a large program or department. Manage regulatory inspections
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Scientific and Regulatory Affairs Expert

Bactolife is looking for an experienced scientific and regulatory affairs expert...

Location

Denmark , København

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Collaborative team player with a proven ability to build and maintain strong, long-lasting relationships
Result- and solution-oriented, with a genuine interest in supporting business development
10+ years’ experience within Regulatory Affairs or related areas, preferably with vast experience from the food tech and/or consumer health space
Experience with precision-fermented/GMM-derived ingredients dossier preparation and approval
Good understanding of Novel Food regulations in EU and/or in the Asia-Pacific region
Excellent communication skills and the ability to connect with external stakeholders such as expert consultants, customers and authorities
Good project management skills and attention to detail
MSc or PhD in a relevant field, Biotechnology, Biology, Chemistry, Microbiology, Nutrition or other related scientific disciplines

Job Responsibility

Identify and work with expert consultants from the Asia-Pacific region
Prepare food ingredient dossier submission, registration, and renewal strategies for products within the region to gain and maintain market access
Support local consultants in engaging with key external stakeholders and local authorities in pre- and post-submission meetings
Understand and guide health claim options and substantiation hereof for different consumer product categories such as health/dietary supplements
Conduct compliance reviews and provide daily support to the business development team in preparing and executing customer pitches and dialogues
Support the regulatory tasks/questions to EU novel food approvals, our business development as well as our clinical research activities

Fulltime

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

Clinical Support Tech 3

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

20.31 - 27.42 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Associate's degree in Laboratory Sciences and technical training closely related to this position required
1 year of laboratory experience preferred
Or equivalent combination of education and experience
Familiarity with medical terminology preferred

Job Responsibility

Performs a diversity of technical assignments which are broadly outlined, require some theoretical insight and occasionally require the interpretation of results
Exercises complex skill and judgment, and knowledge of the principles and methods of a technical field
Serves as a resource to physicians, nurses and other laboratory personnel regarding specimen handling and processing
Manages and maintains department schedules for staff in the Automated Lab
Authorizes requests for time off, approves subsequent changes to the schedule and communicates changes to appropriate individuals
Prepares and posts master schedule six weeks in advance
Ensures adequate staffing levels
Posts vacancies and assists staff with filling full or partial shifts
Schedules employees and new hires for mandatory in-services and continuing education programs
Monitors staff compliance for annual competency and required in-services

Parttime

Clinical Suppt Tech 3

As a community, the University of Rochester is defined by a deep commitment to M...

Location

United States of America , Rochester

Salary:

20.31 - 27.42 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Associate's degree in Laboratory Sciences and technical training closely related to this position required
1 year of laboratory experience preferred
Or equivalent combination of education and experience
Familiarity with medical terminology preferred

Job Responsibility

Performs a diversity of technical assignments which are broadly outlined, require some theoretical insight and occasionally require the interpretation of results
Exercises complex skill and judgment, and knowledge of the principles and methods of a technical field
Serves as a resource to physicians, nurses and other laboratory personnel regarding specimen handling and processing
Manages and maintains department schedules for staff in the Automated Lab
Authorizes requests for time off, approves subsequent changes to the schedule and communicates changes to appropriate individuals
Prepares and posts master schedule six weeks in advance
Ensures adequate staffing levels
Posts vacancies and assists staff with filling full or partial shifts
Schedules employees and new hires for mandatory in-services and continuing education programs
Monitors staff compliance for annual competency and required in-services

Fulltime

Microbiology Development Tech

MillenniumSoft Inc

Location:
United States , El Paso

Category:
Manufacturing

Contract Type:
Not provided

Salary:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 11, 2026

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Additional Information:

Job Posted:January 11, 2026

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January 11, 2026