DUTIES:

• Responsible for generating workbook for costing on New Proposals

o   Ensure completion of all quote activities including amendments for changes of scope in a timely manner

o   Obtain input with technical team and/or quote team to provide support in the department 

o   Issue 2-3 new straight forward quotes per week independently

o   Resource Load project plans for awarded business

• Provide project tracking reports to Senior Management as required
• Other duties as required

QUALIFICATIONS:

• Minimum Bachelor level education in Science or Commerce
• Minimum 2 years pharmaceutical industry experience (preferred areas include product development, project management, manufacturing, regulatory or quality assurance)
• Working knowledge of pharmaceutical drug development processes
• Excellent written and oral communication skills
• Proficiency with the English language
• Demonstrated commitment to our fundamental principles of Respect, Excellence & Integrity.
• Ability to prioritize multiple tasks
• Detail-oriented

• Process/manufacture products in accordance with written processing orders
• Prepare manufacturing areas and equipment for the production of pharmaceutical products
• Clean processing equipment and rooms in accordance with written Standard Operating Procedures (SOPs) and established Good Manufacturing Practices
• Ensure product quality meets the standards of Patheon, our clients, and applicable regulatory agencies including, but not limited to the Health Products and Food Branch Inspectorate (HPFBI), United States Food & Drug Administration (FDA), and European Medicines Agency (EMEA)
• Follow the required Environmental Health and Safety (EH&S) and Good Manufacturing Practices requirements
• Other duties as required

• High school Diploma
• Minimum 1 year experience in pharmaceutical, food or cosmetic related manufacturing
• Ability to lift up to 40 lbs.
• Must be able to work well with limited supervision in a team environment.
• In this role it is essential to perform shift work
• Must have good organizational, documentation and housekeeping skills.
• Proficiency with the English language.
• Demonstrated commitment to our fundamental principles of Integrity, Respect & Excellence

DUTIES:

Engineering Design and Project Management

Design, direct, control and monitor engineering projects using Project Management process to assure that the designs and specifications will achieve the full desired objective of the project, focusing on reduced costs, improved productivity, quality and Good Manufacturing Practices compliance.

Engineering Construction Supervision and Start-Up of a Project

Direct, control and monitor construction phases of engineering projects to assure that the project is implemented per the established scope, on time, and within budget.  Assure compliance with all Good Manufacturing Practices required documentation for all installed equipment.

Project Administrative Tasks

Control, audit, and be accountable for project costs to assure that approved funds are effectively utilized.  Track project costs and authorize payments to contractors.

Maintain project records and communicate to supervision and upper management project costs, status, and safety conditions

Serve as facility and utility technical consultant to the site

Work with internal or external clients to troubleshoot problems, recommend solutions, and provide designs.  Attend design review and project planning meetings.  Share knowledge and assist training entry level engineers.

Promote and facilitate the company’s growth in facility and utility technology

Other duties as required.

QUALIFICATIONS:

· Minimum Bachelor of Applied Science in Mechanical Engineering, Chemical Engineering or related discipline.

· Minimum 5 years experience in project management within a pharmaceutical or food manufacturing environment.

· Ability to work with minimal supervision

· Proficiency with the English language

· Proficiency using Microsoft Office applications

· Strong judgment, decision making and trouble shooting skills.

· Excellent organizational and communication skills (both written and oral).

· Demonstrated commitment to our fundamental principles of Integrity, Respect & Excellence

DUTIES:

• Lead the design/evaluation of formulations and manufacturing processes for solid, semi-solid or liquid dosage forms.
• Lead development of new formulations and scale-up procedures of solid, semi-solid or liquid dosage forms at the pre-clinical, clinical and post marketing stages of drug development.
• Manage resources in their PPT work group to achieve project and team objectives.
• Lead/participate in problem solving for formulations, equipment and processes.
• Develop realistic proposals and timelines and write development reports.
• Write protocols for feasibility work, manufacturing batch records and clinical trial materials. 
• Write and ensure timely execution of protocols and provision of results in accordance with cGMP and company standards.
• Coach people in their work group in e.g. drug development process, PDS systems.
• Liaise with Project Management, Facility/Equipment Schedulers, Materials Management, Analytical Development and other functional areas to meet project and team objectives.
• Participate in relevant meetings/teleconferences with clients; may involve travel to client sites.
• Maintain expert knowledge of pharmaceutical processes, equipment, instrumentation and procedures necessary to perform the tasks. Keep current with scientific literature and industry trends relating to process technologies; disseminate relevant information.  Key technical leadership role in CEI; look for opportunities for publication/external presentations
• Other related duties as assigned

QUALIFICATIONS:

• Minimum B.Sc. in pharmaceutical science or technology, M.Sc. or Ph.D. preferred
• Minimum 4 years of experience in drug development.
• Extensive knowledge and understanding of the drug development process.
• Demonstrable organizational skills relevant to drug development.
• Excellent written and oral communication skills; computer literate.
• Established leadership and organizational skills.
• Experience in technical/scientific discussions with clients.
• Established quality, regulatory, and production mindset including an appreciation for client service and the contract manufacturing industry.
• Works independently with minimal need for intervention by more senior management.
• Able to execute own work which is typically planned by others.
• Proficiency with the English language.
• Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence

• Perform formulation, scale up, and other manufacturing related assignments and document them appropriately.
• Participate in the maintenance of manufacturing and laboratory instruments and equipment.
• Participate in training of equipments.
• Participate in inter departmental coordination for documentation and equipment related tasks.
• Other related duties as assigned

• Minimum B.Sc. in Pharmaceutics, Engineering, or Chemistry.
• Minimum 1year pharmaceutical formulation experience or pharmaceutical manufacturing experience.
• Basic understanding of formulations and processes.
• Knowledge and familiarity with cGMP guidelines.
• Computer proficient.
• Excellent written and oral communication skills.
• Proficiency with the English language.
• Able to execute own work which is typically planned by others.

Duties:        

• Perform formulation, scale up, and other manufacturing related assignments and document them appropriately.
• Participate in the maintenance of manufacturing and laboratory instruments and equipment.
• Participate in training of equipments.
• Participate in inter departmental coordination for documentation and equipment related tasks.
• Other related duties as assigned

Qualifications:

• Minimum B.Sc. in Pharmaceutics, Engineering, or Chemistry.
• Minimum 1year pharmaceutical formulation experience or pharmaceutical manufacturing experience.
• Basic understanding of formulations and processes.
• Knowledge and familiarity with cGMP guidelines.
• Computer proficient.
• Excellent written and oral communication skills.
• Proficiency with the English language.
• Able to execute own work which is typically planned by others.

DUTIES:       

• Prepare and execute protocols and write reports
• Responsible for reviewing documents for assigned team members
• Responsible for technical expertise and support to Quality Operations/Business or Project management/operations/PPT
• Provide guidance to junior members on various validation requirements (through team meetings and individual interactions)
• Reviewing master batch records, deviations and maintenance reports
• Attending client meetings as validation representative
• Individual must ensure their SOP training is current. (ongoing)
• Working on special projects (as required)
• Responsible for updating assigned Master Validation Plan (MVP) as per validation policy. (as required)
• May be essential to perform alternating or rotating shift work (as required)
• Other duties as required

QUALIFICATIONS:

• Minimum B.Sc. or post secondary diploma in Chemistry, Engineering, or related field.
• Minimum 5 years experience in validation within the pharmaceutical industry.
• Ability to work well independently and in a team based environment.
• Excellent computer skills (Microsoft Word and Excel)
• Superior writing skills as well strong accuracy and attention to detail.
• Excellent interpersonal skills, communication and organizational skills
• Strong judgment, decision making and trouble shooting skills.
• Ability to multi-task, meeting tight deadlines in a fast paced environment.
• Proficiency with the English language.
• Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence.