AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality…
Skills: Technical Writing, GMP Compliance, Process Development, SOP Authoring, Change Control Management
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AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality…
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$77k/yr
Full-time
postgraduate degree
Group Health & Dental Benefits, RRSP Matching Program, Perkopolis, Employee Assistance and Wellness Programs, Parking Allowance
Posted 36d ago
~40 hrs/week
Responsibilities
The role involves authoring and managing the full lifecycle of GMP technical documentation, including SOPs, batch records, and validation reports for radiopharmaceutical manufacturing. It also requires coordinating with cross-functional teams to ensure documentation aligns with regulatory requirements and client timelines.
Requirements
Candidates must have a Master's degree in Chemistry, Chemical Engineering, or a related life science and at least 3 years of experience in a pharmaceutical GMP environment. Strong scientific writing skills and the ability to translate experimental data into regulatory-compliant documentation are essential.
Full job description
AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About the Role
The Scientific and Technical Writer, Process Development is an advanced-level documentation specialist embedded within the Process Development team. This role provides hands-on technical, scientific, and operational writing support to process chemists/scientists, and manufacturing operators across development, validation, and clinical supply programs.
The incumbent authors, reviews, and manages a broad range of GMP documentation supporting process development, radiopharmaceutical manufacturing, and technology translation. The role works cross-functionally with internal departments and external stakeholders and requires strong scientific judgment, organization, and attention to detail.
This posting is for an existing vacancy to support the expansion of the company.
Location: AtomVie Global Radiopharma Inc, Hamilton ON (Onsite).
What You Will Do
Plan, implement, and successfully complete assigned documentation related to process development, validation, and radiopharmaceutical manufacturing while ensuring high quality and GMP compliance.
Ensure documentation activities align with client-driven timelines; work with management to accommodate shifting priorities and last-minute changes.
Author, revise, own, and manage the full lifecycle of technical and quality documentation, including, but not limited to, standard operating procedures (SOPs), master batch records, control forms, process development reports, non-conformance reports, CAPAs, root cause analyses, risk assessments, etc.
Initiate, manage, and close change controls and associated CAPAs in a timely manner.
Collect and compile supporting data and documentation for change control submissions.
Improve and develop documentation templates to support efficiency and consistency.
Coordinate document development and review with colleagues within the Process Development team and act as a documentation point of contact for cross-functional stakeholders.
Support documentation requirements related to new equipment purchases and installations (e.g., URS, SOPs, validation documentation).
Prepare documentation summaries and presentations for internal and client-facing reviews; participate in client meetings as required.
Provide guidance and mentorship on technical writing best practices and data presentation.
Escalate deviations or documentation issues promptly to appropriate management.
Must stay current with Health Canada, FDA, and EU GMP requirements for sterile pharmaceuticals, International compendia (USP, EP, JP), and Internal business processes and work orders.
What You Bring to the Role
Minimum 3 years of hands-on experience in a pharmaceutical GMP environment with demonstrated expertise in quality and technical documentation.
Proven scientific writing experience, including technical reports, development documentation, or peer-reviewed publications.
Ability to interpret experimental data and translate scientific results into clear, structured, regulatory-compliant documentation.
Experience supporting process development, manufacturing, or technology transfer programs.
Strong written and verbal communication skills in English, with excellent grammar and composition.
Proficiency with standard office software (Word, Excel, PowerPoint, Project).
Solid understanding of GMP regulations and pharmaceutical documentation practices.
Ability to work independently and collaboratively in a cross-functional scientific environment.
Strong time-management and prioritization skills with the ability to manage multiple deliverables.
Flexibility to support a 7-day operational environment as required.
Frequent walking between buildings, manufacturing suites, and/or transit between sites.
Requirements
Master’s degree in Chemistry or Chemical Engineering. Master’s degree in life sciences, pharmaceutical sciences, or engineering disciplines will also be considered.
Background in organic chemistry, process chemistry, or related disciplines is an asset.
Compensation: Annual salary starts at $77k.
AtomVie Offers
Group Health & Dental Benefits (from day 1)
RRSP Matching Program
Perkopolis
Employee Assistance and Wellness Programs
Parking Allowance
AtomVie does not use artificial intelligence or automated decision-making tools in any part of the recruitment, screening, or selection process.
We are committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
AtomVie Global Radiopharma Inc. ("AtomVie"), incorporated in late 2021, is a global leading CDMO for the GMP manufacturing and distribution of clinical and commercial radiopharmaceuticals and the most recent spinout from the Centre for Probe Development and Commercialization (CPDC). AtomVie offers the full range of scientific, technical, regulatory, quality, logistics and business expertise combined with a specialized infrastructure for the development of your radiopharmaceuticals from Phase 1 to the commercial marketplace. With a state-of-the art purpose-built facility that will be operational in Q4 2025, AtomVie empowers the development of your radiotherapeutics. For more information about AtomVie, visit our website or contact: [email protected].
Offices: 10 Aeropark Blvd, Hamilton, Ontario L0R 1W0, CA · 1280 Main St. W, NRB-A316, Hamilton, Ontario L8S 4K1, CA
How many Manufacturing jobs are open in Hamilton, Canada right now?
There are currently 278 open manufacturing positions in Hamilton, Canada listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Hamilton, Canada?
Companies currently hiring include L3Harris Technologies, American Iron & Metal (AIM), Radwell International, Johnson Electric, Orlick Industries Ltd, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Hamilton, Canada?
Yes — 11 of the 278 open manufacturing positions offer remote or hybrid work (0 remote, 11 hybrid).
How do I apply for Manufacturing jobs in Hamilton, Canada?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.