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

Perform sanitization duties in the cleanroom while aseptically gowned. Accurately record and complete documentation as required, including logbooks and forms in compliance with SOP guidelines. Remove and collect all used disinfectant solution waste and place in the appropriate disposal unit. Administrative tasks including attendance of regularly scheduled departmental mee

Perform Packaging and Labeling of Vials or Syringes. Visual Inspection, Area Line Clearance, and Equipment Sign off. Material Verification. Product Offload. Vial and syringe Counting qualified. Finished Product Labeling. Transfer and proper documentation of Product storage and removal. Follow all proper gowning procedures. Responsible for Good Documentation Practices. Per

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

Serves as department technical writer for investigations, including but not limited to excursion, deviation, preventive actions and out of specification reports. Develops technically justified recommendations and resolutions to investigation conclusions and ensures timely completion of reports, corrective actions and associated activities. Reviews and approves lot specifi

Maintains process equipment in use ready state. Major equipment includes aseptic fillers, isolators, vial washing machines, ovens, and autoclaves. Monitors, responds to, and corrects issues generating process, process support, and laboratory equipment alarms. Completes CMMS entries and required training activities. Travels between facilities to support all functional area

Identifies and resolves all purchasing related issues and manages suppliers associated with respective commodities. Prepares and issues purchase orders, change notices, and product returns. Manages, reviews, and negotiates contracts for optimal pricing, terms, and conditions. Maintains proper documentation practices of purchase orders, agreements, and change orders. Utili

Assists in regular follow ups with end users to ensure timely completion of open investigations and investigation activities. Assist in ensuring the adequacy of investigations performed in relation to manufactured drug product and drug substance to support the batch release process. Provides quality support in the review and approval of quality reports including deviation

Supports the Stability group in performance of sample pulls, scheduling, inventory count, paperwork, organization, and LIMS stability study and sample submission entry with minimal supervision. Authors new stability protocols and revise existing stability protocols with minimal supervision. Provides stability report results to be sent to clients with supervision. Data Rev

Leads all aspects of quality assurance at the facility to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules. Manages key quality assurance metrics/site goals, supports critical program milestones, and drives continuous improvement initiatives that are essential to meeting client and business needs. Establi

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

Responsible for determining applicability, developing content, and facilitating SHE training programs such as new hire orientation, annual refresher training, and specialized SHE training. Maintains SHE documentation systems. Coordinates and participates in emergency preparedness activities such as; building evacuation lists, evacuation drills, Incident Response Teams, an

Under the guidance of senior manufacturing operators, performs various routine manufacturing tasks while adhering to the guidelines of established Standard Operating Procedures (SOP's) and cGMP regulations. Supports the implementation of production and manufacturing procedures. Performs visual inspection of tanks and bulk drug substances. Prepares components, media, buffe

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