MANUFACTURING - ENGINEERING
J. Edgar and Associates Inc. has been serving the High Tech and Pharmaceutical arenas 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.
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:
hbotkin@sympatico.ca and phone Herb
Botkin at 416 225-8071 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, mailto:careers@jedgarcareers.com
PHARMA MANUFACTURING PRINCIPAL ENGINEER, to
$100kplus bonus, FLA
We are currently seeking a Principal Engineer in Manufacturing to provide support and identify process improvement opportunities for manufacturing and packaging processes. The incumbent will be in charge of process project coordination, follow-through problem solving, efficiency studies while providing training and work direction to other engineering staff and handling more complex engineering responsibilities.
Other responsibilities include interfacing with QA and R+D on process requirements for new and current products and develop plans for implementation of new product lines and new equipment while troubleshooting equipment and processes in the manufacturing and packaging areas. The role will make recommendations regarding on site transfer projects and product scale-up activities and plays a lead role in implementing changes.
The position also works with Maintenance to identify recurring problems by researching new equipment, new control systems and process improvement optimization while advising on new equipment that better meets regulatory requirements.
You must have a Bachelors Degree in Engineering and at least 10 years of process engineering experience in the pharmaceutical industry. CGMP, FDA experience in a regulated pharmaceutical manufacturing environment (OSHA, FDA, EPA, AQMD).
Assets include: Solid dosage manufacturing, Industrial Engineering Experience, Lean Initiatives or Six Sigma, Dry and wet blend granulation, fluid bed granulates, high shear granulators, blenders, mills, multiple tablet presses and tablet coaters and packaging equipment systems such as slat fillers and cappers.
Salary range is $95-100K plus 15% bonus.
Location: Florida
Relocation Package: Thorough and generous.
Call Jason Edgar at 416 225-2628, mailto:careers@jedgarcareers.com
PRODUCTION
SHIFT MANAGER, cGMP Operations, to 95K, GTA
We are currently seeking a Production Shift Manager to coordinate shift activities in a cGMP and fully compliant pharmaceutical production environment.
As the Shift Manager, you will be responsible for performing some tasks and delegating others with the responsibility of follow up.
Main Duties include: Ensure production requirements are met to satisfy or exceed forecast demand, participate in the development and implementation of performance improvement strategies to increase productivity and improve quality, provide leadership and motivation to initiate creative thinking to support continuous improvement, evaluate activities of the set up mechanics and the technical processes to ensure production and quality demands are met, initiate training and development programs to improve performance on a continual basis. You will be called upon to recommend training as necessary to include technical, safety and cGMP’s as appropriate with overall responsibility for the efficient operations of the production areas. You will ensure the scheduled production as per the weekly production schedule is completed in a timely manner and provide sharing of production issues, progress and initiatives from one shift to the next to facilitate an efficient working environment. You will work with the other shift managers and the Director of Operations to determine the department budget and ensure the shift shop floor control processes are being monitored and closed at the completion of orders.
You must have experience with high speed packaging lines, c-GMP knowledge as related to compounding/packaging equipment design, operation and maintenance and computer literacy using BPCS, Microsoft Word, Excel, Scheduler, Project. We’re looking for someone with good mechanical aptitude. It is important to have the flexibility to work on different shifts and on weekends.
Solid investigation abilities including the ability to perform root cause analysis is essential as is good working knowledge and understanding of cGMP’s and compliance. The ideal candidate has strong interpersonal skills and ability to provide leadership and motivation. Strong communication skills, written and verbal, in order to communicate effectively with all departments and prepare documentation as required is essential.
A University degree in Science or Engineering is required with at least 5 years experience in a cGMP compliant environment including 3 years of Supervisory or management experience.
Salary range is $90-95K.
Call Jason Edgar for all the details at 416 225-2628, mailto:careers@jedgarcareers.com
DIRECTOR, QUALITY OPERATIONS –
Pharmaceutical – to $130K – GTA
We are currently seeking a capable Quality specialist to manage and direct the activities of Microbiology, Validation, Compliance, QA, and Technical Services in a large pharmaceutical Manufacturing environment.
As Leader for the Group, you will be responsible for the direct management of QA, QC and Compliance groups while assisting and motivating all departments cross-functionally. You will be called upon for leadership for HPB/FDA audits as well as the regulatory awareness programs for each agency. Assisting in the development of cGMP and GLP policies for all departments, you will lead the FDA and HPB audit response teams.
You must have at least 5 years of experience in Quality Operations management to be able to maintain monthly reports, departmental budgets and complete reviews of appropriations. The Director of Quality Operations will also provide technical support to Pharmaceutical Sales, Client Services, PDS, Operations and individual clients.
You must have a B.Sc. in Chemistry, Pharmacy, Microbiology or a related science with a minimum of 5 years in Senior Quality management within big Pharma. Extensive FDA audit and audit response experience is required.
Salary is in the $115-130K range. Bonus and full benefits apply.
Call Jason Edgar at 416 225-2628 mailto:careers@jedgarcareers.com
MASTER
SCHEDULER to 65K, Toronto, Ontario
We are currently seeking an experienced Industrial Engineer who has managed
and coordinated the production schedule for contract maintenance in a food or pharmaceutical manufacturing setting.
The position is responsible for the execution of weekly and monthly schedules for each packaging line. Creating an efficient schedule
with maximizing output by managing operating costs is a big part of the position.
Other Duties:
Responsible for creating weekly packaging schedule.
Review shortage report and confirm availability of material.
Create a constraint/ exception report.
Communicate weekly frozen schedule
Communicate the shortages or critical items required to execute the plan to QA/QC, purchasing and warehousing
Responsible for organizing contract manufacturing.
Create shop packets, shipments to the vendors, confirm delivery dates
Attend daily production meetings with QA/QC, operations
· To assist Shop floor coordinator to create shop packets
· To hold meeting with Contact manufacturers to communicate commitments
· To work with the Packaging Engineer to confirm validation and exhibit batches status.
Requirements:
University degree or diploma in Industrial Engineering.
2-3 years experience in scheduling and planning in Food or pharmaceutical industry. APICS designation or enrolled inventory
Salary is in the $60K to $ 65K range.
Call Cris or Jason at 416 225-6386 for full details, mailto:jedgar@sympatico.ca