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The Senior Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting audits and supporting inspections, and maintaining quality databases. The ideal candidate will assist with the development of SOPs or other quality documents as needed. The Senior Compliance Specialist will perform the role of Lead Inspector for external audits and act as consultant with clients for all levels of regulatory issues. The Sr. Compliance Specialist will provide guidance and mentoring for other compliance employees.
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The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing...
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The Senior Manager, Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Senior Manager, Quality Operations provides leadership to the site Quality team who performs quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives, directs the implementation of quality plans, and works with lab management to ensure department goals and objectives are met. The Senior Manager interacts with clients and regulatory agencies...
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The Sr. Scientist II is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this position, Titrations, CKF/KF, dissolution and/or CCIT based methodologies are commonly employed in the described compendial testing. Other key methodologies applied include: TLC, HPLC, GC, UV.
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The Sr. HVAC/R Technician is responsible for performing routine and emergency maintenance during business hours, unless otherwise notified of an emergency on Alcami’s laboratory and building refrigeration, air conditioning, and heating systems. Availability is required to respond to equipment emergencies. The Sr. HVAC/R Technician is the Subject Matter Expert (SME) responsible and accountable for preventing excursions for CTUs. This includes providing guidance to end users as well as assisting with design and maintenance. This will be achieved through the creation of procedures and checklists combined with consistent compliance with each by yourself and team...
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The Shipper/Receiver - Pharma/GMP is responsible for the safe and proper handling of client products in accordance with company procedures and client specific requirements. This shipper/receiver position is challenged with a daily routine that changes based on client demand and generally takes place in a fast-paced work environment at varying environmental conditions.
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The Senior Scientist I, Bioassay is accountable for driving results in a fast-paced environment by performing routine and non-routine testing in support of pharmaceutical product development and manufacturing. The Sr. Scientist I, Bioassay may also be required to work on method development and method validation projects. The Senior Scientist I, Bioassay will demonstrate strong knowledge in cell-based potency assays, ELISA, real-time PCR, enzymatic activity assays, binding kinetic assays and other biochemical testing methods. Also, knowledge in techniques such as HPLC, icIEF, or CE-SDS is desirable. Strong problem-solving and troubleshooting skills along with proficiency in analyzing data, laboratory documentation, data presentation and collaboration will help...
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The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing engineering support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: evalutation of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.
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The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed.
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The Scientist - Formulations is accountable for driving results in a fast-paced environment and leading formulation development studies for the design and identification of safe, stable, robust and manufactural pharmaceutical dosage forms. The Scientist - Formulations independently designs, plans, performs, interprets and reports results of scientific experiments for the preparation and timely delivery of drug products (DP), processes and procedures needed for technology transfer and manufacture of the product. The position requires superior leadership behaviors as well as expertise in functional competencies including scientific principles, laboratory practices, cGMPs and regulatory requirements for pharmaceuticals and biologicals.
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The Associate Director, Laboratory Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Associate Director, Laboratory Quality Operations provides leadership to the site Quality team who perform quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives; directs the implementation of quality plans and works with lab management to ensure department goals and objectives are met. The Associate Director, Laboratory...
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The Senior Manufacturing Maintenance Technician is accountable for driving results in a fast-paced environment by directly supporting a wide range of service disciplines covering HVAC systems, mechanical and electrical troubleshooting, mechanical equipment repair and general maintenance in an FDA registered pharmaceutical processing environment. The Sr. Manufacturing Maintenance Technician operates in a highly technical fast paced environment requiring experience related specifically to keeping production business running. The Sr. Manufacturing Maintenance Technician applies critical thinking and considers all business impact aspects before taking job related actions that could cause unwanted consequences such as loss of revenue, unsafe events, and other...
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The Director, Manufacturing Sterile Operations is accountable for driving results in a fast-paced environment by providing leadership to the site’s manufacturing function. Focus areas for the role include operational leadership, parenteral (Filling and Visual Inspection) manufacturing process, project management, continuous improvement, change management, manufacturing investigations/corrective actions, participation in business reviews, and support of regulatory and client audits.
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The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employ acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician I works collaboratively to support other manufacturing areas as required.
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A Senior Scientist I - Mass Spec is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. The Scientist III is also required to work on method development/method validation projects. For this position, HPLC, LC/MS and GC/MS based methodologies are commonly employed in the described testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).
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The Sr. Metrologist is accountable for driving results in a fast-paced environment by performing calibration and diagnostics repair of process instrumentation including pressure, temperature, flow, relative humidity and mass in pharmaceutical manufacturing and laboratory environments. A fundamental knowledge of clean utilities systems including WFI and Clean Steam is required. Additional experience with analytical instrumentation including HPLC, gas chromatography, and laboratory equipment desired. Maintaining calibration of metrology standards and completing and reviewing calibration documents. The ideal candidate will use computerized equipment and software to perform testing functions and produce graphs.
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The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed.
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The Sr. HVAC/R Technician is responsible for performing routine and emergency maintenance during business hours, unless otherwise notified of an emergency on Alcami’s laboratory and building refrigeration, air conditioning, and heating systems. Availability is required to respond to equipment emergencies. The Sr. HVAC/R Technician is the Subject Matter Expert (SME) responsible and accountable for preventing excursions for CTUs. This includes providing guidance to end users as well as assisting with design and maintenance. This will be achieved through the creation of procedures and checklists combined with consistent compliance with each by yourself and team members. The individual in this...
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The Supervisor, Compendial Testing supervises and coordinates the activities of the assigned operation area and provides technical leadership for the assigned operations area. Expected to coach, train, and develop skills of the subordinate staff. The Supervisor, Compendial Testing will interact with clients and manufacturing and is responsible for successfully meeting client and departmental objectives in a timely manner.
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The Calibration Field Technician I performs routine calibration and preventive maintenance of Alcami and customer equipment. Calibration may include temperature, relative humidity, CO2, voltage, pressure, time, rotation, etc. following documented procedures using precision standards. Calibrations and Preventative Maintenance will be performed in-house and at customer sites. Create, modify, and execute calibration procedures and calibration certificates. Perform testing to support the quality management system and report, troubleshoot and make recommendations about quality issues relating to calibration. Assist in filing, data entry, and general record keeping.
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The Sr. Scientist I, Microbiology is accountable for driving results in a fast-paced environment by performing more complex microbial analysis and assisting in method development and validation. This position takes on the role of troubleshooter and trainer and will provide direct assistance to manufacturing and cleanroom qualification efforts. The Sr. Scientist I, Microbiology participates more actively in lab investigations and corrective and preventative actions. The role initiates procedural revisions and performs editing and review functions. The Sr. Scientist I, Microbiology may serve as a primary technical contact with clients.
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The Senior Validation Engineer will plan, schedule, coordinate, and track all facets of assigned validation projects. Develop highly specific protocols and execute complex systems. The Sr. Validation Engineer will execute protocols for Installation, Operational and Performance Qualification testing on chambers and rooms including: autoclaves, cryo-freezers, cold rooms, refrigerators, incubators, sterilizers, depyrogenation ovens, stability chambers, and warehouses. Also, Steam in Place (SIP) validation using biological indicators and projects requiring specialized knowledge or expertise (GMP manufacturing facilities and equipment, computerized systems). Process, assemble and review data, generate documentation and reports. The Sr. Validation Engineer will be a...
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The SAP ABAP Developer will be responsible for designing, developing, testing, and supporting custom solutions and enhancements across SAP environments. This role combines strong expertise in traditional ABAP development (ECC and S/4HANA) with modern, cloud-native capabilities on SAP BTP. The developer will work closely with functional consultants, business analysts, and cross-functional stakeholders to translate requirements into robust, compliant, and scalable solutions. This is a hands-on technical role with broad impact—contributing to innovation, automation, and continuous improvement in a regulated pharmaceutical manufacturing environment.
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The Sr. Validations Specialist is accountable for driving results in a fast-paced environment by supporting general pharmaceutical validation of equipment and GxP computerized systems. Specific responsibilities include reviewing SOP’s, composing/revising SOP’s and validation master plans; supporting facility, utility, manufacturing equipment, conducting reviews of validation documentation such as validation plans, system/functional requirements, protocols and summary reports; ensuring compliance with 21 CFR Part 11, Data Integrity, and functional requirements; developing documentations as required for projects; serve as the subject matter expert during audits and inspections and consulting on validation and cGMP questions and issues. The ideal candidate...
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The Director, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the Biologics department within Laboratory Operations. The Director, Laboratory Operations - Biologics is responsible for the success of site operations and achieving company goals. This position requires a balance of scientific expertise, business acumen, and customer focus to ensure high-quality services, efficient execution, and sustained growth. The...
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The Senior SAP EWM / Manufacturing Integration Lead is accountable for driving operational excellence through hands-on support and optimization of SAP S/4HANA, with primary focus on Extended Warehouse Management (EWM) and integration with manufacturing (PP/PTM processes). This role plays a critical part in stabilizing and enhancing Alcami’s SAP landscape following our recent RISE with SAP go-live.
The ideal candidate is a hands-on practitioner who works directly in the system to support warehouse execution and production material flow, partnering closely with Manufacturing, Warehouse Operations, Quality, Supply Chain, and IT. This individual will lead day-to-day EWM execution, troubleshoot integration issues, implement practical improvements, and help...
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The Director, Pharma Storage is accountable for driving results in a fast-paced environment. The Director, Pharma Storage is a client-facing position responsible for regional oversight on behalf of the Pharma Storage department providing leadership and mentorship to all operations personnel within the region.
The Director, Pharma Storage ensures that Pharma Storage activities are executed in compliance with industry regulations, data integrity, and the quality management system. This leadership role manages short and long-term goals of the operation and implements and manages projects to ensure deadlines are met.
This role acts as a point of...