Process Engineering II

JOB DESCRIPTION

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

Division/Site Specific Information:

Our Mississauga facility covers all phases of drug product development from  early-phase formulation development to clinical trial material to  commercial supply in the same plant using scalable equipment for non-GMP and GMP work.

Discover Impactful Work:

Support the 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.

• Investigate quality issues could include system control, Quality Investigation Report (QIR)/ Quality Deviation Report (QDR) .

• Investigate root causes and recommen d appropriate Corrective Action/Preventative Action (CAPA) items for the Technical Operations department (using tools such as FMEA, RCA, etc).

• Generate technical documents ( protocols , reports, proposals, gap/risk assessment, batch records, URS, etc) .

• Generate, a ssess , and 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 and design and acquis i tion of equipment .

• Perform batch analysis .

• Attend project team meetings, client teleconferences and on-site visits .

• I nteract with clients daily .

• Work closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activities and a ttends 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-secondary diploma in Chemistry, Engineering, Science or related field.

BSc in Chemistry or Engineering is an asset.

Experience:

Minimum 3 years of experience within Pharmaceutical Manufacturing or Quality Assurance departments

Minimum 2 years of combined hands on pharmaceutical experience in Production and Development (scale up and technology transfer of solids and liquids).

Minimum 1-year experience in Master Batch Record/Protocol/Report preparation within the Pharmaceutical Industry, including proven abilities in report writing and batch record preparation required

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 skills and communication skills.  Ability to multi-task, meeting tight deadlines in a fast paced environment.   P roven 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: s afety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

Excellent Benefits

• 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 estimated annualized pay range for this position in Ontario is $56,400.00–$84,600.00.