Model Risk Analyst III - Validation
M&T Bank$82,783 - $137,972/year
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Validation Engineer - Pharmaceutical Sterile Manufacturing at Acadia Pharmaceuticals
Sacramento, California, United States
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, HealthcareIndustries
Requirements
- Bachelor's degree or Diploma in Pharmaceuticals, or a related field
- Minimum 2 years of experience in a pharmaceutical manufacturing or validation role, with a focus on sterile manufacturing (e.g., aseptic processing, sterile filling, isolator, autoclave sterilization)
- Strong understanding of cGMP, FDA, EMA, ISO standards, and other relevant regulatory requirements
- Experience with equipment validation (e.g., filling machines, autoclaves, and HVAC systems) and process validation
- Familiarity with the documentation requirements for validation, including protocols
Responsibilities
- Perform or oversee the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment and systems
- Qualify equipment in sterile manufacturing facility (e.g., aseptic processing, sterile filling, isolators, autoclave sterilization)
- Ensure compliance with regulatory requirements for equipment qualification and validation
- Knowledge of validation equipment like Kaye validator, temperature and RH data loggers etc
- Prepare and review validation reports to ensure they meet regulatory and company requirements
- Maintain traceability of validation activities and ensure all validation records are accurately documented, maintained, and stored
- Conduct and manage process validation studies to confirm the sterility and quality of pharmaceutical products
- Work with cross-functional teams (e.g., production, quality control, engineering) to optimize manufacturing processes and ensure consistency and repeatability
- Support the development and implementation of new processes, ensuring that they are validated per regulatory requirements
- Knowledge of cleaning validation will be an added advantage
- Perform any additional tasks as assigned by the Validations Lead
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What compensation and benefits does Nivagen offer?
Nivagen offers competitive pay, comprehensive benefits, and robust training and development opportunities to prioritize employee well-being.
Is this position remote or onsite?
The position is onsite at Nivagen Pharmaceuticals Inc. in Sacramento, CA.
What key skills are required for the Validation Engineer role?
Key skills include performing IQ, OQ, and PQ for sterile manufacturing equipment like aseptic processing, sterile filling, isolators, and autoclaves; knowledge of validation equipment such as Kaye validator and data loggers; and expertise in process validation, cleaning validation, cGMP, FDA, EMA, and ISO standards.
What is the company culture like at Nivagen?
Nivagen fosters a culture of excellence, integrity, respect for people, growth, and support, with collaborative teams driving innovation in healthcare.
What makes a strong candidate for this Validation Engineer position?
Strong candidates have experience independently managing the validation lifecycle in sterile pharmaceutical manufacturing, including IQ/OQ/PQ, process and cleaning validation, and compliance with cGMP, FDA, EMA, and ISO standards.
Acadia Pharmaceuticals
Develops therapies for neurological disorders
About Acadia Pharmaceuticals
Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.
Dallas, TexasHeadquarters
1993Year Founded
$813.4MTotal Funding
ACQUISITIONCompany Stage
Biotechnology, HealthcareIndustries
501-1,000Employees
Benefits
Health Insurance
Dental Insurance
Vision Insurance
401(k) Retirement Plan
401(k) Company Match
Employee Stock Purchase Plan
Paid Vacation
Paid Holidays
Paid Sick Leave
Paid Parental Leave
Tuition Reimbursement
Risks
Increased competition in CNS drug market may impact Acadia's market share.
Potential clinical trial delays could affect drug approval timelines.
Dependence on partnerships poses risks if collaborations face challenges or dissolve.
Differentiation
Acadia focuses on CNS disorders with unmet medical needs, like Parkinson's and Rett syndrome.
The company has a strong R&D foundation, developing innovative small molecule drugs.
Acadia's strategic partnerships enhance its research capabilities and market reach.
Upsides
Acadia's collaboration with Saniona expands its portfolio with SAN711 for neurological disorders.
Health Canada's approval of Daybue boosts Acadia's presence in the Canadian market.
The rise of personalized medicine aligns with Acadia's targeted therapy approach.
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