Cleanroom Fill Lead Job at Fagron (Wichita)

Manufacturing Manager

The Manufacturing Front Line Manager (FLM) at Amgen Dun Laoghaire is a key membe...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering or science
Knowledge of relevant regulations and regulatory requirements (GMP, EH&S)
5+ years’ experience in Syringe aseptic manufacturing operations or demonstrated capacity to learn quickly and adapt to new technology
Previous experience in managing and leading teams
Understanding and use of RFT techniques and lean manufacturing concepts
Excellent people management skills, including performance management, coaching, mentoring, and team development
Ability to lead, challenge, and positively influence in a team environment
Proficient computer skills - knowledge of Electronic Batch Records (PAS/X), Quality tracking system (QMTS), and personnel performance tracking (MAPs)
Demonstrated ability to work within an AI Mindset
Fluent English required

Job Responsibility

Model Amgen’s values and leadership attributes, ensuring all cleanroom activities meet the highest standards of quality and safety while adhering to the manufacturing schedule
Manage a shift of Process Technicians to achieve production targets efficiently in accordance with GMP, safety, and other regulatory standards
Facilitate daily scheduling and team meetings to align all groups on critical activities to meet the manufacturing plan
Support the commissioning, qualification, and product transfer of Amgen’s drug products to the new filling line
Drive problem-solving efforts on the shift, working with cross-functional teams to minimize schedule disruptions
Act as Aseptic Coach by observing and advising on aseptic practices in the manufacturing clean rooms
Ensure the team compiles, maintains, and reviews all necessary reports and documentation, including batch records/EBRs, using appropriate systems and SOPs
Collaborate with Quality groups (QCC/QCM/QCI and QA), Materials Management, Maintenance, Technical Services, and Human Resources to achieve department objectives
People management, including team development, engagement and ongoing performance reviews via the Maximizing Amgen’s Performance (MAP) process, ensuring clarity and accountability for expected performance levels
Identify training needs and facilitate completion per Amgen’s Learning Management System and production requirements

What we offer

Comprehensive employee benefits package, including health and welfare plans for staff and eligible dependents
Retirement and savings plan with generous company contributions
Group medical, life and disability insurance
Discretionary annual bonus program
Exceptional learning, development, and career advancement opportunities

Fulltime

Production Supervisor

Provide technical and planning leadership to the Production Filling team to ensu...

Location

United States , Stillwater

Salary:

73000.00 - 100000.00 USD / Year

Diasorin

Expiration Date

Until further notice

Requirements

H.S. Diploma or equivalent education required
Associates or Bachelor’s Degree preferred
2+ Years serving in a supervisory/lead role required
5+ Years of production experience with demonstrated increase in responsibilities required
Supervisory experience required
Experience with OSHA Regulations required
Cleanroom experience required
Service in a life science/medical device field with lyophilization knowledge desirable
Bottling and labeling machines
GMP and ISO regulations

Job Responsibility

Provide technical and planning leadership to the Production Filling team to ensure that the primary filling, lyophilization and labeling functions are performed according to company and customer specifications
Provide technical leadership especially related to product filling / processing / labeling
Review and update manufacturing documents for accuracy and completeness
Develop documents for use in manufacturing products as new technological information becomes available
Identify areas for process and process improvements and develop plans and strategies to achieve these improvements
Act as a major resource in areas of expertise
Provide training and support to employees
Develop minimum competences within the group
Lead training within the group
Participate in the development and delivery of internal training programs

What we offer

competitive rewards package
comprehensive plan of health benefits
retirement and financial wellbeing
time off programs
wellbeing support and perks
annual incentive program

Fulltime

Associate Director, Sterility Assurance

The Associate Director, Sterility Assurance, DP Manufacturing is a senior techni...

Location

United States , Norwood

Salary:

142500.00 - 256500.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Life Sciences, Pharmacy, or related field (Master's or Ph.D. preferred)
8+ years in sterility assurance, quality control, sterile pharmaceutical manufacturing, or aseptic processing roles
Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations
Strong expertise in risk assessment facilitation
Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership
Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations

Job Responsibility

Lead and maintain the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with EU Annex 1, FDA aseptic guidance, and internal quality expectations
Ensure practical, risk-based integration of the CCS into isolator operations, cleanroom design, gowning practices, material and personnel flow, environmental controls, and aseptic process execution
Provide sterility assurance expertise for site changes, process improvements, and operational decisions that may impact contamination control
Provide expert sterility assurance guidance on the EM program (strategy, zoning, sampling design, alert/action levels, and trending) and partner with QC to ensure effective monitoring and response aligned with contamination control strategy
Lead or support investigations with potential impact to sterility assurance (e.g., EM excursions, media fill failures, decontamination issues, bioburden or sterility failures), ensuring robust root cause analysis and effective corrective and preventive actions
Present EM performance, contamination control risks, and key trends to site leadership and drive data-based decision-making
Own and author sterility assurance-related Quality System documentation, including change controls, risk assessments, CAPAs, deviations, and other records associated with contamination control, EM, or aseptic practices
Ensure records are scientifically sound, timely, and aligned with site and global quality system requirements
Serve as a key leader in inspection and audit readiness activities, including internal audits, client audits, and regulatory inspections
Act as subject matter expert for CCS, EM, aseptic execution, isolator operations, media fills, and related sterility assurance topics

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
Eligible for an annual discretionary bonus, other incentive compensation, or equity award

Fulltime

Global Business Development Manager

SP Industries Inc., an ATS Company is seeking an experienced Global Business Dev...

Location

United States , Warminster

Salary:

Not provided

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

7+ years of experience in pharmaceutical, biopharma, or life science capital equipment or system solutions, with a strong focus on aseptic processing and/or lyophilization
Proven track record of closing large, complex, multi million dollar pharmaceutical system deals with biopharma, biotech, diagnostics, or CDMO customers
Demonstrated ability to build and convert a global sales pipeline, including direct ownership of opportunity creation, deal progression, and bookings
Working knowledge of EU GMP Annex 1 and its impact on aseptic lyophilization system design, automation, contamination control, and customer requirements
Practical understanding of GAMP 5 principles, including computerized systems, controls, data integrity, and validation expectations in regulated environments
Experience selling or supporting fully integrated aseptic system solutions, including lyophilizers, automated loading/unloading, material handling, and associated system architectures
Ability to engage credibly with senior customer stakeholders across engineering, manufacturing, quality, and executive leadership
Experience operating in a player coach capacity, combining direct commercial responsibility with leadership of technical SMEs or solution specialists
Bachelor’s degree in engineering, life sciences, or a related technical discipline
Willingness to travel globally 30-50%

Job Responsibility

Own and drive global revenue growth across the aseptic and non aseptic lyophilization portfolio, with direct accountability for closing large, complex, high value pharmaceutical and biopharma capital equipment and system solutions
Define and execute the global commercial strategy for lyophilization systems, leveraging strong understanding of lyophilization cycle development, formulation considerations, CIP/SIP systems, and sterility assurance requirements to deliver differentiated, value based solutions
Serve as a senior commercial and technical authority across non-aseptic and aseptic filling and lyophilization, with strong working knowledge of EU GMP Annex 1, FDA expectations, cleanroom classifications, isolators/RABS, aseptic process simulations, validation strategies, and quality risk management
Lead the sale of fully integrated system solutions, including lyophilization, automated loading and unloading, material handling, controls, and supporting architectures—positioning SP as a total solution partner rather than a standalone equipment supplier
Apply practical knowledge of GAMP 5, computerized systems, and validation expectations to support compliant system design discussions, risk mitigation, and customer confidence throughout the sales process
Build, qualify, and actively manage a robust global pipeline, including ownership of forecasting, financial modeling, and business case development to support accurate revenue planning and strategic investment decisions
Personally engage senior customer stakeholders across engineering, manufacturing, quality, procurement, and executive leadership to influence complex buying decisions, support contract negotiations, and close strategic, multi site opportunities
Lead and develop a team of lyophilization commercial based subject matter experts, setting clear commercial priorities, driving accountability, and ensuring technical depth directly supports deal execution and customer success
Partner cross functionally with engineering, product management, project management, manufacturing, and service teams to shape commercially viable offerings, influence service strategies, and ensure end to end solutions meet customer, regulatory, and operational requirements
Maintain a strong understanding of biologics, vaccines, small molecule injectables, and sterile drug products, along with global outsourcing drivers, capacity constraints, and competitor capabilities impacting the lyophilization and aseptic processing market

What we offer

We provide a wide range of innovative and high-quality scientific products that improve people’s lives
We offer a robust health and welfare benefits package that includes Life, Health, Dental, Vision
We offer 401(K) including company match, Paid Time Off annually + Paid Holidays
You will enjoy career Advancement Opportunities and Tuition Assistance to help you achieve your goals and continue your career growth

Fulltime

Operational Excellence Specialist

The Operational Excellence (OpEx) Specialist is a key driver of performance, com...

Location

United States , Canton

Salary:

Not provided

Fagron

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Life Sciences, Operations, or related field
3+ years of experience in pharmaceutical manufacturing, ideally in a 503B, 503A, or cGMP sterile environment
Working knowledge of Lean, Six Sigma, and structured problem‑solving tools
Strong understanding of aseptic processing, sterile filtration, and cleanroom operations
Ability to analyze complex data sets and translate insights into actionable improvements
Excellent communication and facilitation skills

Job Responsibility

Lead and facilitate Lean initiatives (5S, standard work, visual management, value stream mapping) across ISO‑7 and ISO‑5 operations
Identify bottlenecks in compounding, filtration, filling, and inspection workflows
implement sustainable solutions that improve flow and reduce cycle time
Conduct time studies, labor modeling, and capacity analysis to optimize staffing and equipment utilization
Develop and maintain KPIs and dashboards that drive daily performance management
Lead structured problem‑solving (DMAIC, 5‑Why, Fishbone, Fault Tree) for deviations, complaints, and recurring operational issues
Partner with QA to ensure CAPAs are data‑driven, effective, and closed on time
Support investigations related to aseptic behavior, environmental monitoring trends, filter validation gaps, and equipment performance
Develop and refine SOPs, batch records, and work instructions to ensure clarity, consistency, and audit readiness
Translate complex technical requirements into technician‑friendly procedures without compromising compliance

What we offer

competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry

Fulltime

Process Engineer | Scientist | Med-Tech

We're supporting a cutting-edge med-tech company developing a new manufacturing ...

Location

Australia , Brisbane

Salary:

100000.00 - 140000.00 AUD / Year

Reqiva

Expiration Date

Until further notice

Requirements

Minimum 2-5 years' experience in process engineering / process development
Background within pharmaceutical, medical device, or GMP-regulated environments
Experience working with aseptic processes, cleanrooms, or regulated manufacturing
Strong understanding of process validation, qualification (IQ/OQ/PQ), and GMP standards
Hands-on mindset with the ability to work on the floor and solve real-world problems
Strong communication skills and ability to work within cross-functional teams

Job Responsibility

Support the qualification of a new cleanroom and manufacturing equipment
Develop and validate aseptic manufacturing processes (including media fills)
Contribute to the design, optimisation, and transfer of manufacturing processes
Ensure processes meet PIC/S GMP and regulatory requirements
Lead or support process troubleshooting, root cause analysis, and continuous improvement
Assist in developing process documentation, protocols, and validation reports
Work cross-functionally with engineering, quality, and operations teams

What we offer

Work on a globally significant biotech innovation
Be part of a high-impact clinical programme
Join a team building new manufacturing capability

Fulltime

Compounding Supervisor

As the Cleanroom Supervisor you will assist pharmacists and room supervisors ove...

Location

United States , Wichita

Salary:

85000.00 USD / Year

Fagron

Expiration Date

Until further notice

Requirements

7 years of experience working in a regulated environment
Minimum of 3 to 5 years’ experience in a leadership position (i.e., Shift of Line Leader, Group Leader, etc) or demonstrated leadership abilities
Good working knowledge of all functional areas of the inspection and packaging area
Solid math and effective problem-solving skills with demonstrated use of sound judgement
Good communication and organizational skills, strong interpersonal skills
Demonstrated ability to work effectively and lead a team
Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management
Ability to take initiative, including asking for and offering help when needed
performs work independently without being prompted
Strong attention to detail and focus on quality, accuracy, and accountability

Job Responsibility

Successfully pass and remain qualified for entrance into the ISO 7 cleanrooms
Successfully pass media fill and remain qualified to assist with tasks within the ISO VLFH as required
Must be able to stand and maneuver around the tight spaces of a cleanroom for upwards of 7 hrs. per day
Assist in overseeing all ISO 7 cleanroom activities including but not limited to: cleaning of VLFHs, the preparation of materials required to aseptically reconstitute, pool and dilute drug product, manual aseptic filling of drug product, performing calibration checks and environmental plating of operators
Must be able to rapidly assess situations, trouble shoot production concerns, guide operators, and effectively communicate complex detailed information to management outside of the cleanrooms via electronic tools frequently and quickly
Ensuring compliance to SOPs, batch records and HR policies, assisting in disciplinary action as needed
Meet Right First Time (RFT) metrics by reducing error / deviations and completing corrections quickly
Review and maintain adherence to the manufacturing schedules
Track employee training to ensure compliance
Aid in bi-annual reviews of procedures

What we offer

Competitive salary
Comprehensive benefits
Performance package
Ability to be part of an international leader in an expanding industry

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

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Cleanroom Fill Lead

Job Description

Job Responsibility

Requirements

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