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.
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 - firstname.lastname@example.org
MANAGER CAPITAL PROJECTS PHARMACEUTICAL ENGINEER TO 110K PLUS BONUS, GTA
We are currently seeking an experienced Manager of Commissioning and Qualification (C&Q) is responsible for the administration of the Commissioning and Qualification activities at the Toronto manufacturing site. This position will report to the Associate Director, Site Engineering and will be a key contributor to the Site Engineering team. The Manager C&Q will work closely with key stakeholders in a variety of departments within the manufacturing sites to assure all design changes, commissioning needs, and operational support requirements are met.
Responsibilities will include: Acting as primary C&Q interface with Project Management and Quality functions. Leading the use of the site C&Q Program and ensure alignment with corporate standards along with engineering best practices. Being responsible for the management, mentoring and development of C&Q staff. Leading development, approval, execution, resolution and reporting of all project specific engineering C&Q documentation. You will be responsible for project documentation management and quality of the Engineering Turnover Documentation as well as administration of training for site commissioning and qualification methods to execution team. Managing commissioning and qualification phase advancement. Monitoring/evaluate contractor safety performance throughout the duration of the project. Providing oversight to project contractors to ensure Site C&Q Program methods are being utilized per procedures.
You should be a self-starter with strong interpersonal, organizational, and technical skills working both independently and in a team environment. This position requires strong analytical and communications skills are including written and verbal presentation skills to support interactions with engineering management. Strong mentoring and development experience is required. You must be able to establish strong working relationships with stakeholders (Quality, Manufacturing, and MTech) to ensure high quality deliverables meeting CGMP and site quality requirements.
Required Qualifications: Demonstrated knowledge of cGMPs and expertise in current commissioning and qualification methods utilizing industry guidance for applied risk management methods for the commissioning and qualification of manufacturing systems in a biopharmaceutical manufacturing environment. Demonstrated C&Q expertise in process automation, building automation systems and distributed control systems, working knowledge of CGMPs, sanitization and passivation, and Biopharmaceutical Manufacturing. Experience in a CGMP industry is required, Biotech preferred. Experience with current commissioning and qualification methods, including ISPE, ICH, and ASTM E2500 methodology. Knowledge of HPFBI & FDA regulatory requirements pertaining to bio-processing facilities. 5 years’ functional management experience preferred.
Location - Toronto - Salary - $90-110K - Bonus - 10%
Jason Edgar at 416 225-2628 - resumes to email@example.com
Resumes in Word format to
Cris Murray 416 225-6386. Resumes in Word format to firstname.lastname@example.org
BIOMEDICAL TECHNICAL SUPERVISOR, to $ 70K, plus bonus, Montreal
We are looking for a biomedical / electronics technician or engineer with 2- 4 years experience in scheduling and fulfilling service requests for haemodialysis customers in Quebec. Your responsibilities will include training staff, equipment installation and evaluation, creating, updating and implementing ISO procedures, responding to customer service issues, ensuring compliance to standards and procedures including regular metre checks.
You will be responsible for planning and scheduling all installations and evaluating requests for purchasing in addition to ensuring all equipment is current. Your organization and scheduling experience is critical as you will create and maintain an after-hours on-call schedule to provide seamless customer service. Also, you will provide technical phone support, maintenance and repairs as required.
As part of the sales support efforts, you will contribute to customer meetings and follow-up with prospective customers to provide continuity. Of course familiarity with Word, Excel, Access and Lotus Notes is preferred.
Head Office: Montreal area
Travel in the province of Quebec: 30%
Bilingual: Excellent communications skills in French and English, spoken and written
To apply for this position: email your updated CV in Word format to: email@example.com and phone Herb Botkin at 905 832-7588 in Toronto.
PROJECT MANAGER, ENGINEERING, PHARMACEUTICAL, to $120K plus bonus, USA
We are currently looking for an Engineer to manage improvement projects at one of our Pharmaceutical client sites. Under the general direction of the Associate Director of Engineering, the incumbent Project Manager will lead, coordinate and manage facilities, equipment and process/systems projects including analysis, design and implementation. As PM, you will oversee and manage major improvement studies while overseeing design and construction work related to facility and utility related improvements and capital projects.
Some functions and responsibilities include; preparing GMP draw-ups and ROI data sheets, managing vendor consultant selection for design and construction services as related to capital projects and studies including preparation of RFP documents, preparing detailed schedules and estimates for capital projects, preparing URS/FRS/DRS and Basis of Design Documents, managing and maintaining budgets and schedules, coordinating permitting process on construction projects with design and construction firms as well as reviewing and validating design calculations.
As Engineering Project Manager you will also: Inspect construction installations and prepare punch lists, perform and/or supervise commissioning/start ups, troubleshoot and evaluate facility related equipment, manage major improvement studies as well as all functions relating to the planning, design and implementation of facility equipment and process/system projects while ensuring compliance with SOP’s, cGMP’s, FDA and EU requirements.
You must have experience with; Operations of a pharmaceutical facility, Computer operations and applications including AutoCAD, MS Project, Excel, Power Point, Principles and practices of budget preparation and administration, Management practices and principles, English usage, spelling, grammar and punctuation as well as current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements practices. A strong background in pharmaceutical facility HVAC, mechanical, electrical and process design will get you an interview right away.
Your academic background must include a degree in Chemical, Mechanical or Electrical Engineering or a related discipline and a minimum of 10 years project design engineering and construction management for facility, utilities and process equipment, with a strong background in the pharmaceutical industry. HVAC and piping experience is required. Pharmaceutical manufacturing experience is preferred. Solid supervisory, management or project leadership experience is required. Project management certification and graduate degrees are excellent assets for this position.
Salary range: $110-120K plus Bonus.
Location: California, USA.
Call Jason Edgar for all the details at 416 225-2628, firstname.lastname@example.org