MANUFACTURING - ENGINEERING

   

J. Edgar and Associates Inc. has been serving the Manufacturing Industries since 1992. We source Supervisory and support staff for Management, Engineering, Quality, and Materials. If you are currently in the market for a new employment opportunity, we invite you to view the current opportunities below.

Check frequently for the latest hot jobs...Process Engineering Manager...Manager Clinical Supplies


 PROCESS AND MECHANICAL ENGINEERING MANAGER - GMP MANUFACTURING TO 120K, GTA

We are currently seeking an Engineering Manager with at least 7 years of experience and a P.Eng designation to lead the Process and Mechanical aspects of a very productive cGMP environment. This position manages an experienced group of Process Engineers and their Support personnel in resource planning and scheduling for multiple production lines in Pharmaceutical production.   This role will interface with Maintenance, Production Operations, PDS, Commercial and Quality in order to execute equipment, process, product and system's installation, qualification and validation.

Managing and ensuring that all cGMP, Health and Safety, Environment compliance standards are in place and adhered to including up to date processes, SOPs, KPIs, documentation and training are key aspects in this position. As EM, you will also assist in setting engineering project completion dates that align with production, short and long term facility plans and assisting in developing the Engineering capital and operating budget. As EM, you will define, document and implement engineering standards for drawings, specifications, documentation control, software, manuals, test procedures, revision control and configuration.  These items and standards are in place and require update and maintenance as required.

Managing equipment and facility capital projects related to equipment installation or re-location is part of this very focused planning role, this position interfaces with Facilities management regularly. This position oversees the selection, identification and management of contractors and capital projects. This role also works closely with Compliance to provide updates to the Master Validation Plan while overseeing the preparation of protocols/documents for equipment, process and system's qualification/validation.  This position works with Operations Management to lead continuous improvements in terms of design engineering efficiencies, process, quality, safety and problem resolution in compliance with cGMPs. Operational excellence within the Engineering team is a mandate.

You should have at least 7 years of experience in a Pharmaceutical production and Packaging cGMP environment with an Engineering degree in Mechanical or Chemical and a P.Eng designation. You should have a strong understanding of Global Manufacturing Compliance and Technical Standards. Strong MS Project, Visio and AutoCAD skills are essential.

Salary - $110-120K

Please call Jason Edgar at 416 225-2628 for all the details. Resumes to - careers@jedgarcareers.com


MANAGER CLINICAL SUPPLIES/ NEW PRODUCT R+D $170K plus Bonus, USA

We are currently seeking a Manager for Clinical Supply in the early research and development phases of New Drug development.  This position will work closely with Formulations and Materials Management groups, Statisticians, Clinical Research and Data Management teams and other Clinical, Global Drug Safety, Regulatory and Project Management staff to supply Clinical Trial Materials for Clinical Studies.

The Manager will oversee and contribute to the completion of all technical and operational activities for a group of clinical trials for a compound/indication or equivalent through management of internal and external resources. As Manager, you will deal with complex processes across functions and interact with clinical protocol teams including Biostatisticians and Clinicians, Materials Management, QA, formulation and process development and regulatory affairs groups to provide input into the packaging and labeling strategy.

As Manager, the incumbent will oversee a Team of 5-6 reports tasked with planning, implementing and initiating activities on multiple projects related to the labeling and distribution of clinical supplies to ensure clinical supply study start dates are met. Working closely with Clinical, Formulations and Materials management teams to forecast drug supply needs for clinical studies and Managing labeling contractor activities including Contractor selection is a major aspect of this role. As Manager, you will manage the labeling and distribution budget for each related project and be able to write and review SOPs required for labeling and distribution as well as write and review packaging and labeling batch records and label artwork.

Managing external vendor relationships and negotiating contracts while conducting vendor audits with QA is another aspect of this role. You should be able to perform PPS, IQS, RCVS, EQMS and EBS transactions while preparing and approving purchase orders for specific programs.  This position is tasked with management of Clinical Supply inventory at CMO facilities including movement of Clinical Supplies, monitoring inventory levels, resolving issues and working with QA to resolve quality issues with labeling vendors and clinical supply partners.

You must have BS in Pharmacy or a related Scientific field with a minimum of 6-8 years of relevant experience. You must possess a strong knowledge of the FDA, cGMP and GCP standards as well as Regulatory guidance documents such as Annex 13.

 Salary - $150-170K Bonus - 15-20%, Generous Company Incentives - Executive Class Relocation Program

Call Jason Edgar for all the details  416 225-2628, email careers@jedgarcareers.com


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