Associate MSAT Engineer Job at AbCellera Biologics (Vancouver)

Manufacturing Validation Associate II

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS Degree in Science, Engineering or Math with 2 or more years of experience. Master's Degree with 1 or more years of experience
2 years of direct, hands‑on experience writing and executing equipment, process, or cleaning validation protocols in a GMP manufacturing environment
Ability to work at least 5 days onsite in the plant
Demonstrated experience with IQ/OQ/PQ, PPQ, or cleaning validation is strongly preferred
Ability to understand scientific and engineering principles and apply them to manufacturing equipment and process validation challenges
Good interpersonal/communication/influencing/negotiation skills
Strong project management skills
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Proficient in Microsoft Word and Excel, computer software
Some experience with statistical software helpful

Job Responsibility

Execute manufacturing equipment qualification activities (IQ/OQ/PQ) for new and existing production equipment
Support process validation and continued process verification (PPQ/CPV) activities in a GMP manufacturing environment
Lead and support cleaning validation activities, including protocol execution and sampling activities
Be involved in design of experiments (DOE), equipment/process troubleshooting, development of new approaches, and improvement of existing manufacturing methodologies
Generate, analyze, and interpret manufacturing validation data, develop reports, and present results to cross‑functional teams
Schedule, plan, communicate, and manage validation documentation and field execution activities performed onsite in manufacturing areas
Interpret and apply regulatory requirements (FDA, cGMP) related to equipment, process, cleaning, utilities, and facility validation
Apply working knowledge of cGMPs, SOPs, and site procedures to ensure compliant execution of validation activities
Perform validation activities to lead and/or support equipment, process, cleaning, utilities, and facility validations
Provide limited support for validation of manufacturing‑associated computerized or equipment‑integrated systems, as applicable to overall equipment or process validation

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage
Basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Manufacturing Validation Associate II

Location

United States , Round Lake

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

BS Degree in Science, Engineering or Math with 2 or more years of experience. Master's Degree with 1 or more years of experience
2 years of direct, hands‑on experience writing and executing equipment, process, or cleaning validation protocols in a GMP manufacturing environment
Ability to work at least 5 days onsite in the plant
Demonstrated experience with IQ/OQ/PQ, PPQ, or cleaning validation is strongly preferred
Ability to understand scientific and engineering principles and apply them to manufacturing equipment and process validation challenges
Good interpersonal/communication/influencing/negotiation skills
Strong project management skills
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software helpful
Direct or indirect industry knowledge

Job Responsibility

Execute manufacturing equipment qualification activities (IQ/OQ/PQ) for new and existing production equipment
Support process validation and continued process verification (PPQ/CPV) activities in a GMP manufacturing environment
Lead and support cleaning validation activities, including protocol execution and sampling activities
Be involved in design of experiments (DOE), equipment/process troubleshooting, development of new approaches, and improvement of existing manufacturing methodologies
Generate, analyze, and interpret manufacturing validation data, develop reports, and present results to cross‑functional teams
Schedule, plan, communicate, and manage validation documentation and field execution activities performed onsite in manufacturing areas
Interpret and apply regulatory requirements (FDA, cGMP) related to equipment, process, cleaning, utilities, and facility validation
Apply working knowledge of cGMPs, SOPs, and site procedures to ensure compliant execution of validation activities
Perform validation activities to lead and/or support equipment, process, cleaning, utilities, and facility validations
Provide limited support for validation of manufacturing‑associated computerized or equipment‑integrated systems, as applicable to overall equipment or process validation

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Sr Director, MSAT

The Sr. Director, MSAT (Manufacturing Sciences, Analytics, and Technology) acts ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences or equivalent experience required
Minimum of fifteen (15) years of relevant experience in cGMP manufacturing or equivalent
Proven experience leading innovation, managerial experience with extensive industry knowledge and an eye towards future technologies
Soft skills: Strategic thinking, adaptive thinking, and strong critical mindset. Strong business acumen and presentation skills. Excellent interpersonal, leadership, and communication skills. Impact & influence top leaders & external clients and regulators
Emphasis on aseptic processing and compliance required
Advanced-level verbal communication skills

Job Responsibility

Optimize the use of resources (human, fill finish equipment and support areas) across the organization in support of improving process robustness and forward-looking capabilities
Coordinates and supports cross functional teams with recommendations, advice, and action plans for complex investigations, change controls, gap analyses and risk assessments related to all manufacturing modalities
Oversees authoring and revision of compliance, change controls and other technical documentation to support critical MSAT changes
Assesses incoming client projects to ensure compatibility, compliance, and initial and ongoing profitability with AAI processes
Contributes advanced level support to internal and client audits when needed
Build and sustain common innovation roadmap between MSAT and Drug Product Manufacturing/Finishing to ensure continuum in innovation to accelerate client projects and sustainable process performance
Lead the client technical intake process team composed of engineers and specialists
Drive complex change management & anchor the changes in MSAT and with connected functions, Drug Product, Finishing, Quality Assurance and Quality Control
Responsible for exhibiting professional behavior with both internal and external business associates that reflect positively on the company and is consistent with the company’s policies and practices
Serves as key contact for clients during tech transfer and post manufacturing activities

Fulltime

Head of MSAT

An amazing opportunity has arisen for a Head of MSAT (Manufacturing Science and ...

Location

United Kingdom , Dundee

Salary:

Not provided

Argenta

Expiration Date

Until further notice

Requirements

Proven experience in a manufacturing environment including successful drug product technical transfer projects
MSc. In Science, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent experience
8-12 + years in manufacturing and technical project management experience in a pharmaceutical environment, with progressive leadership experience
Knowledge of GMP and FDA manufacturing regulations
Ability to analyse and interpret data
Strong written and oral communication skills
Experience in examining and re-engineering operations and procedures, and developing and implementing new strategies and procedures
Demonstrated expertise in pharmaceutical formulation, process development, or manufacturing technology
Demonstrated knowledge & awareness of current industry issues & evolving trends in the regulated environment
both domestically & internationally

Job Responsibility

Leadership of MSAT & AS&T teams, including proactive development of team members, ensuring that the technical competencies/knowledge to support the site’s processes are in place, budgetary control, and team performance management
Responsible for managing new product introduction and process improvement activities throughout the site (processes and associated documentation)
Implements safe and GMP compliant working practices in the function, and ensures team perform their duties accordingly
Provide technical support and troubleshooting support to production team at site
Ensure products are validated and remain in constant state of validation throughout the manufacturing life of the product within a site (including continuous monitoring)
As a key member of Site Leadership team, work to develop site strategy, implement site performance KPI’s, and translate these into specific annual performance goals
Act as the senior escalation point for key clients and stakeholders by building strong relationships with customers and partners

Fulltime

Life Cycle Management Consultant Pharmaceuticals

We are seeking a detail-oriented Lifecycle Management Specialist Consultant with...

Location

Belgium , Beerse

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, Engineering, or a related life sciences field
4–6 years of professional experience in pharmaceutical manufacturing, operations, MSAT, or technical support within a GMP environment
Proven knowledge of primary packaging materials (e.g., glass, elastomers) and their use in parenteral drug product filling processes (vials, syringes, cartridges)
Hands-on experience with change control systems, comparability protocols, and supplier change management
Strong understanding of cGMP regulations, quality systems, and lifecycle management principles
Fluency in English mandatory
Technical Skills & Software Proficiency: Comet (preferred) – for change and document management
Minitab – statistical analysis
SAP – ERP system navigation
Microsoft Office Suite – Advanced Excel, PowerPoint, Word

Job Responsibility

Change Control Management: Lead end-to-end change control processes for supplier-initiated changes to primary packaging materials
prepare and review all associated documentation (assessments, risk evaluations, implementation plans)
Specification Review: Evaluate supplier-provided specifications (e.g., glass vials, stoppers, caps) against internal quality and regulatory standards
Comparability Reporting: Author comprehensive comparability reports to assess impact on processability, product quality, and patient safety
Cross-Functional Coordination: Liaise with Analytical Development, Quality, Regulatory, Manufacturing, and Supply Chain teams to execute technical testing and validation activities linked to packaging changes
Data Analysis & Reporting: Utilize statistical tools to interpret data from process performance, fill-line trials, and stability studies
Compliance & Documentation: Ensure adherence to cGMP, ICH guidelines, and internal SOPs throughout the change lifecycle

What we offer

Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe

Fulltime

Associate Director, Manufacturing Science and Technology

We are seeking a dynamic and experienced MSAT Associate Director to support late...

Location

United States

Salary:

175000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD in relevant discipline (e.g., biology, chemistry, biochemistry, bio/chemical engineering, or relevant field) or commensurate years of education and experience
7+ years of biologics development and manufacturing experience
Experience with late phase development and commercialization of monoclonal antibodies within relevant process areas (upstream cell culture, downstream processing, solution prep, cleaning, automation, data systems, etc.)
Experience with tech transfer to CDMOs and supporting DS campaigns through scale up and validation/PPQ, including person in plant and pre-approval inspection support
Experience with process and economic modeling of DS manufacturing processes
Demonstrated aptitude in collaborating with cross-functional partners, including clinical development/operations, analytical development, QA, RA, and supply chain
Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
Demonstrated growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Ability to multi-task and keep pace with a fast-moving organization
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless

Job Responsibility

Develop and deliver phase-appropriate product understanding and control strategies using QbD framework and risk assessment
Support manufacture of clinical and commercial GMP DS throughout product lifecycle, including tech transfer, campaign analysis, and diagnostics
Author and review technical reports, master and executed batch records, working across internal team and with CDMO partners
Work closely with CDMO partners, providing technical oversight (including onsite Person in Plant support when required), and taking the lead in supporting investigations and resolving deviations
Analyze process and manufacturing data to understand and optimize process performance
Develop process characterization and PPQ strategies and documentation
Support regulatory activities including submissions and site inspections from preparation through execution
Liaise with DP, device development, and clinical supply chain as needed to ensure seamless end to end product delivery and robustness
Develop and maintain cost of good models that describe process and enable sensitivity analyses for process improvements
Collaborate closely with colleagues to ensure a seamless, highly integrated TechOps team

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

New

Plant Quality Control Technician

Help Ensure the Quality of Products Millions of People Trust. Are you passionate...

Location

United States , Commerce

Salary:

23.89 USD / Hour

MMC Group LP

Expiration Date

Until further notice

Requirements

Bachelor's degree in Food Science, Biology, Microbiology, or another related science
at least two years of experience in a similar Quality Control or laboratory environment
Knowledge of microbiological, chemical, physical, and sensory testing methods
Strong analytical, organizational, and problem-solving skills
Experience working with laboratory testing equipment and calibration
Computer proficiency with Windows-based applications
Excellent written and verbal communication skills
Ability to manage multiple priorities in a fast-paced manufacturing environment
Commitment to workplace safety and quality standards
Must be able to lift up to 50 pounds

Job Responsibility

Collecting product samples and performing laboratory testing
Conducting microbiological, chemical, physical, and organoleptic testing
Plating, reading, documenting, and recording laboratory results accurately
Maintaining detailed quality records and performing data entry
Following Quality Control Hold procedures for out-of-specification products
Calibrating laboratory equipment and assisting with troubleshooting
Following Standard Operating Procedures (SOPs) and quality protocols
Monitoring quality trends and communicating findings to supervisors
Supporting continuous improvement initiatives throughout the facility
Assisting with plant sanitation and maintaining 5S standards

What we offer

Medical, dental, and vision coverage
Life and disability insurance
Additional voluntary benefits

Fulltime

New

L3 Support – Pega

Title: L3 Support – Pega Location: Toronto, ON (Hybrid) Experience Required: 6–8...

Location

Canada , Toronto

Salary:

50.00 USD / Hour

Realign

Expiration Date

Until further notice

Requirements

Strong Pega Platform experience (CSA/PCSA or equivalent): Tracing, clipboard, rules debugging, job schedulers, queues
Solid Java / Spring Boot troubleshooting (APIs, microservices)
Hands-on experience with: Dynatrace (RCA, dashboards, alerting), Splunk (log queries, analysis, dashboards)
Experience in L3 Production Support model
Strong working knowledge of: ServiceNow (Incident / Problem / Change), JIRA / JTFM defect management lifecycle
Experience in RCA-driven issue resolution and MTTR management
Essential: L3 Support Pega, KYC
Additional: Know Your Customer (KYC), Digital – Pega

Job Responsibility

Own end-to-end resolution of L3 incidents via ServiceNow, including RCA and closure within SLA
Perform deep technical analysis across Pega, Spring Boot services, integrations, and database layers
Utilize: Splunk for log analysis, correlation, and triage Dynatrace/DataDog for performance analysis and dependency mapping
Support and monitor: Batch jobs, schedulers, queue processors, listeners, and application health
Raise, track, and manage defects in JIRA / JTFM, including: Detailed RCA documentation, Mapping production issues to backlog items, Driving fixes to closure with Dev teams
Participate in daily defect triage calls and ensure alignment between production issues and JTFM tracking
Execute and validate standard, emergency, and release-related changes
Collaborate with L2, Development, Infrastructure, and vendor teams for incident triage, escalation, and resolution
Maintain runbooks, KT artifacts, and audit-compliant documentation
Identify proactive monitoring gaps, alert tuning opportunities, and automation improvements

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Associate MSAT Engineer

Job Description

Job Responsibility

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