The Contamination Control Manager is responsible for leading, developing, and continuously enhancing the company’s established integrated contamination control strategy within a biologics Contract Development and Manufacturing Organization (CDMO) environment. Role works closely with Manufacturing, MSAT, and Quality to drive proactive identification, reduction and elimination of contamination risks across multiple facilities, client products & processes.
Responsibilities
Lead development and maintenance of the site Contamination Control Strategy (CCS) aligned with global regulatory expectations (including UK/EU GMP Annex 1, FDA & ICH guidelines).
Ensure contamination control principles are embedded across Supplier and Service Provider Selection and Management, Facility and Equipment Design, Process Flows (open and closed systems), Facility and Equipment cleaning, sanitisation, sterilisation, pyrogen reduction, and material/personnel/waste flows, Learning & Development curricula.
Adapt contamination control strategies to effectively support diverse client processes, modalities and manufacturing technologies.
Partner with Manufacturing to integrate contamination control into Shift routines and pre-job briefs, aseptic behaviours and operator practices, Day-to-day decision making on the floor, Training and capability building.
Collaborate with MSAT to embed contamination prevention during Equipment detailed design and specification, Tech transfer and scale-up activities, Process characterization and control strategy development, and Introduction of new client processes and products.
Requirements
Bachelor’s degree in microbiology, biology, biochemistry, chemical engineering, or related discipline
Nice to have: Master’s Degree
Nice to have: Experience supporting tech transfer into commercial manufacturing
Nice to have: Hands-on involvement with EU GMP Annex 1 implementation
Nice to have: Experience preparing sites for regulatory inspections and client audits
Assist in developing the structure to aseptically operate Formulation, Wash/Sterilization, Filling & media preparations through documentation, start-up and validation activities for a new production facility.
Compensation
Leading pay and annual performance bonus for all positions
Responsibilities
Review & author Job Instructions, SOP’s & other documents
Assist in the start-up and validation of new equipment
Review standards to maintain aseptic areas & perform sanitizations & environmental monitoring
Support event response planning
Assist maintenance team in the development of protocols for restoration of lost function, predictive & preventative maintenance
Lead process optimization and engineering initiatives at Schreiber Foods’ Monett plant, focusing on dairy upstream processes, capital projects, and food safety compliance.
Responsibilities
Optimize upstream dairy processes including blending, standardization, heat treatment, filtration and sanitation
Develop and drive engineering strategies for processing line capability and capacity
Design and implement improvements to enhance yield, reduce waste, increase throughput and streamline operations
Collaborate with Operations Excellence and Data Science teams to leverage data for process optimization
Lead or assist in new equipment installations or modifications, from concept to commissioning
Requirements
Bachelor's degree in Engineering; Chemical or Process Engineering
Ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA Audits, investigations, training, and recommendations to improve processes / procedures.
Compensation
The salary range for this position is:
$58,500.00 - $84,500.00
Responsibilities
Ensure a constant state of inspection readiness and that audit observations are addressed on time and completed to maintain readiness levels.
Provide daily floor coverage to support compliance of production (aseptic processing areas (sterile gowning a prerequisite), development, and testing (AQL – eye testing a prerequisite) of all products within functional areas.
Audit areas to ensure compliance with cGMP, regulatory, and internal requirements.
Perform Parallel and CCA Sampling as required by the business
Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation.
The QC Specialist II - Aseptic Processing plays a key role in monitoring product quality and patient safety through laboratory testing, scientific research, and monitoring aseptic processes to ensure meeting high quality and compliance standards.
Compensation
€47,100.00 - €87,500.00
Responsibilities
Handle OOS/deviations, define CAPAs, and follow KPI trends
Ensure all activities comply with cGxP, including data integrity control and approval of analytical data/tests and stability
Stability testing within projects: drafting protocols, evaluations, and reports
Reporting, including the drafting of stability plans, trend analyses, and evaluations
Perform stability studies, protocols, and comparative reports for supplier qualification
Requirements
Bachelor's degree in Pharmaceutical Laboratory Technology
Develop, implement, and maintain QA systems in alignment with USP , , , state board of pharmacy regulations, and other applicable standards
Monitor, document, and investigate reported adverse events or product complaints and ensure timely reporting to appropriate regulatory bodies, and implement follow-up actions including root cause analysis, trending, and corrective measures in accordance with pharmacy policies and applicable laws
Conduct and/or oversee routine audits of sterile and non-sterile compounding processes, facilities, equipment, and documentation
Review and approve compounding records, batch release documents, and standard operating procedures (SOPs)
Investigate deviations, non-conformances, and out-of-specification results; lead root cause analysis and ensure appropriate corrective and preventive actions (CAPAs)
Requirements
Doctor of Pharmacy (PharmD)
Bachelor of Science in Pharmacy
Nice to have: 1+ year in a quality assurance or compliance-related role
Senior Specialist, Technical Operations – Engineering to support FLEx Sterile Expansion Project, focusing on Optima multi-use filling line commissioning and qualification.
Compensation
$117,000.00 - $184,200.00
Responsibilities
Collaborate with stakeholders on equipment and facility design, maintenance, and troubleshooting
Provide training on advanced troubleshooting and support functions to operators and engineers
Support project assignments and aid in facility and process equipment innovation
Perform manual and automated operations, general maintenance, troubleshooting and support functions
Perform aseptic manipulations within Grade A barrier isolation systems
Requirements
B.A./B.S. in Mechatronics, Engineering, Automated Sciences, Computer Science, Biology, Chemistry or equivalent
Master’s degree with a minimum of 3 years relevant experience
Nice to have: automated aseptic filling lines
Nice to have: smart technologies such as robots, automated systems
Pharmaceutical Operator - FFEx APNewNovo Nordisk A/S · Clayton, US
QA Sterility Assurance LeadNewten23 health AG · Visp, Switzerland