Process Engineer

Job summary

Serve as the technical subject matter expert for assigned pharmaceutical client accounts, troubleshooting escalated manufacturing issues and responding to client and auditor questions. Prepare and maintain GMP documentation, support ongoing client initiatives, and coordinate documentation, scale-up, and technology transfer activities.

Job details

We are seeking a Process Engineer to support a portfolio of 6–7 commercial-stage pharmaceutical client accounts within an Oral Solid Dose (OSD) manufacturing environment. This role combines process engineering expertise, GMP documentation, and technical subject matter expertise, with direct collaboration with clients and regulatory stakeholders. The position is primarily desk-based, with most of the time focused on technical analysis, GMP documentation, and client and regulatory correspondence. Floor presence is limited and primarily required for escalated troubleshooting. Location: Whitby, ON Work Mode: Onsite, 5 days/week Duration: 6 months, with possible extension Key Responsibilities Act as the on-site technical SME for an assigned client portfolio, troubleshooting manufacturing issues escalated from the floor that operations cannot resolve independently (occasional floor presence, approximately 30 minutes per day) Generate and maintain GMP technical documentation, including batch records, technical and investigation reports, feasibility protocols, and scale-up reports Serve as the direct technical point of contact for clients and regulatory/quality auditors, answering process- and equipment-related questions on behalf of operations Maintain continuity on active client initiatives handed off from the outgoing process engineer Coordinate as needed with technical writers (documentation support) and technical project leads (scale-up and tech transfer projects) Qualifications 1–2 years of hands-on OSD process engineering or manufacturing experience, OR approximately 5 years of general pharmaceutical GMP experience (e.g., liquid dose, sterile) for candidates without direct OSD background Technical knowledge of core OSD unit operations and equipment, including: Granulation: fluid bed, high shear, roller compaction; Compression: tablet presses (e.g., Elizabeth Hata, Korsch) and capsule filling; Coating: film/cosmetic coating, O'Hara pans. SAP experience required Comfort ramping up on proprietary systems and the QMS platform (TrackWise); training provided at start Strong client-facing communication skills Ability to represent operations confidently to external clients and auditors Strong technical analysis and documentation abilities Expected Compensation Range: 100K. The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements. Canadian Experience Requirement: No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience. Artificial Intelligence (AI) Disclosure: No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers. Statement Regarding Job Vacancy: This position is a Job creation, created to support ongoing project needs. Recruitment Process & Feedback Timeline: Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage. Why choose us An international community bringing together more than 110 different nationalities An environment where trust is central: 70% of our leaders started their careers at the entry level A strong training system with our internal Academy and more than 250 modules available A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.) Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

What you’ll do

Serve as the technical subject matter expert for assigned pharmaceutical client accounts, troubleshooting escalated manufacturing issues and responding to client and auditor questions. Prepare and maintain GMP documentation, support ongoing client initiatives, and coordinate documentation, scale-up, and technology transfer activities.

Requirements

Candidates need either 1–2 years of hands-on OSD process engineering or manufacturing experience, or approximately five years of general pharmaceutical GMP experience. Required qualifications include SAP experience, knowledge of OSD equipment and unit operations, strong technical documentation and analysis skills, and confidence communicating with clients and auditors.

Listed skills

• SAP · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• OSD Process Engineering
• Pharmaceutical Manufacturing
• GMP Documentation
• Process Troubleshooting
• Granulation
• Tablet Compression
• Capsule Filling
• Coating
• SAP
• TrackWise
• Technical Analysis
• Client Communication
• Regulatory Audits
• Batch Records
• Scale-Up
• Technology Transfer

Job areas

• Engineering
• Manufacturing
• Healthcare
• Consulting