Process Engineering II
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Job Location:
Mississauga - Canada
Monthly Salary:
$ 56400 - 84600
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Our Mississauga facility covers all phases of drug product development fromearly-phase formulation development to clinical trial materialtocommercial supplyin the same plant using scalable equipment for non-GMP and GMP work.
Discover Impactful Work:
Supportthe Technical Operations department in generation of protocols master batch record review batch analysis Quality Investigation Report/Quality Deviation Report (QIR/QDR) follow-up process execution and equipment procurement.
Day in the Life:
Technology transfer. Responsible for transfers and launches to the site. Includes process scale-up and process optimization.
Investigatequality issuescould includesystem control Quality Investigation Report (QIR)/Quality Deviation Report (QDR).
Investigate root causes and recommendappropriateCorrective Action/Preventative Action (CAPA) items for the Technical Operations department(using tools such as FMEA RCA etc).
Generatetechnical documents (protocols reports proposalsgap/risk assessment batch records URSetc).
Generate assessand approve change controls.
Attend Quality Improvement meetings.
Assist in the coordination of project information between Account Management Quality Assurance (QA) Quality Control (QC) and Commercial Operations.
Support Technical Operations team with process execution/equipment trials anddesign andacquisition of equipment.
Perform batch analysis.
Attend project team meetings client teleconferences and on-site visits.
Interact with clientsdaily.
Work closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activitiesand attends weekly scheduling meetings(if applicable).
Provide training/support to Co-Ops/Interns and monitor ongoing training (if applicable)
Maintain a safe working environment and report potential hazards.
Perform alternating and rotating shift work (as required)
Key to Success:
Education:
Post-secondarydiploma in Chemistry EngineeringScienceor related field.
BSc in Chemistry or Engineeringis an asset.
Experience:
Minimum 3 yearsofexperience within Pharmaceutical Manufacturing or Quality Assurance departments
Minimum 2 years of combinedhands onpharmaceutical experience in Production and Development (scale up and technology transfer of solids and liquids).
Minimum1-yearexperience in Master Batch Record/Protocol/Report preparation within the Pharmaceutical Industry including proven abilities in report writing and batch record preparation
Previous experience in statistical analysis and data compilation an asset.
Previous experience with SAP enterprise software to source information and navigate business operations an asset.
Equivalency:
Equivalent combinations of education training and relevant work experience may be considered.
Knowledge Skills and Abilities:
Knowledge of processing/packaging equipment.Knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures.Strong written and oral skills. Detail oriented and organized with a high degree of accuracy and thoroughness. Excellent interpersonal skillsandcommunication skills. Ability to multi-task meeting tight deadlines in a fast paced environment.Proven problem solving abilities. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.
Physical Requirements:
Light physical effort and fatigue. Walks sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust fumes or odours temperature extremes loud noise strong drafts or bright lights.Use of Personal Protective equipment may be required and may include any of the following: safety glasses safety shoes lab coat gloves hair net beard cover safety apron respirator on occasionally.
Excellent Benefits
- Benefits & Total Rewards Thermo Fisher Scientific
- Medical Dental & Vision benefits-effective Day 1
- Paid Time Off & Designated Paid Holidays
- Retirement Savings Plan
- Tuition Reimbursement
OTHER
- Relocation assistance is NOT provided
- Must be legally authorized to work in Canada now or in the future without sponsorship.
- Must be able to pass a comprehensive background check
Compensation
The salary range estimated for this position based in Ontario is $56400.00$84600.00.Required Experience:
IC
About Company
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