Help Maintain, Troubleshoot and diagnose automated control systems problems, working closely with Facilities Technicians, maintenance and Engineering personnel. Collect and review BMS alarms reviews for completeness. Ensure well documented on time completion of CMMS documentation including logbook entries, Work Orders and Alarm audits. Communicate with supply vendors to c

Performs various semi routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. Acts as the lead in daily operations ensuring all components are in place, operators are trained and all documentation is complete prior to finishing a campaign. Acts as subject matter expert for a specific piece of equipment. Schedules manufacturing tasks und

Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility. Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment. Performs various semi routine manufacturing tasks under the guidelines of established SOP's and cGMP regulations. Troubleshoots manufactur

With guidance, develops at the strategic level, while managing diligent execution at the tactical level. Directs the activities of the drug substance sub groups (upstream, downstream, support services, and investigation groups). Develops and leads high performance management team, directs the recruitment and development of staff. Establishes and communicates high performa

Provides leadership, vision, and management to the Drug Product Manufacturing team, and overall site. Leads all aspects of drug product manufacturing operations at the facility to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules. Manages key manufacturing metrics/site goals, supports critical program mile

Documentation Preparation to include but not limited to the following Authoring of User Requirements and Functional Specifications Authoring of cover protocols for vendor supplied Installation, Operational and Performance protocols Review vendor supplied protocols for completeness of testing per user requirements and function design specifications. Provide validation over

Responsible for performing validation documentation preparation and review for manufacturing process, equipment and utilities in accordance with relevant guidance documents and current industry best practices. Executes validation protocols. May be tasked with training lower level personnel. Acts as Validation subject matter expert for regulatory and client audits. Partici

Writes and executes installation, operational, and performance qualification protocols for critical production equipment, utilities and processes which may include HVAC systems, clean compressed air systems, WFI systems, purified water systems, clean steam systems, nitrogen systems, fermenters, purification skids, vial washers, controlled storage units, autoclaves, depyro

Responsible for full lifecycle project management including scope development, detailed engineering, execution, commissioning, qualification and close out. Support Laboratory & Manufacturing departments in the implementation of new equipment for laboratories, biologics fermentation & purification, aseptic manufacturing and packaging. Partner and manage projects with other

Develops, optimizes, qualifies and/or validates analytical methods using HPLC, LCMS, cIEF, CE SDS, UV and particulate matter quantitation and characterization assays (e.g. HIAC, MFI, DLS and HOUND). Coordinates and executes analytical method transfers between Clients and Aji Bio Pharma. Provides advanced technical problem solving without supervision in method development,

Contributes to customer audit program, including scheduling audits, hosting audits, communicating and coordinating with internal SMEs, responding to audit findings, and tracking completion of corrective actions. Contributes to internal audit program, including generating an audit schedule, conducting audits, writing audit reports, and evaluating responses to audit observa

Supervision of Procurement personnel. Supports creation and implementation of category plans. Monitors purchasing systems and procedures and ensures compliance to company authorizations, policies, and procedures with respect to the purchasing function. Researches suppliers, pricing, cost effectiveness, and availability of material and commodities. Establishes and maintain

Reviews and develops QMS change control practices and policies. Leads program improvement initiatives and collaborates closely with stakeholders to implement solutions. Change control management; leads feasibility assessments and other deliverables. Manages and performs in depth analysis of complex QMS documentation change requests including SOP's, master batch records, m