Validation Engineer - Pharmaceutical Sterile Manufacturing at Acadia Pharmaceuticals

Sacramento, California, United States

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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

cGMP

FDA regulations

EMA regulations

Process Validation

Equipment Qualification

Sterile Manufacturing

Pharmaceutical Manufacturing

Validation Lifecycle

Regulatory Compliance

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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