Senior Specialist, Associate Aseptic Process Validation Engineer

Scorpion Therapeutics; Harvard (MA); On-site; USD 88,000 - 106,000; Full time

Benefits offered by this job

Health coverage

401(k)

Disability and life insurance

PTO options

Wellbeing support

Job summary

Scorpion Therapeutics in Devens, MA seeks a qualified candidate to support aseptic process simulations/validations (APS/APV) and author qualification documents, ensuring manufacturing readiness for APS execution.

You will lead aseptic risk assessments, author impact assessments for monitoring deviations, own site change controls, and serve as an SME to support regulatory inspections and cross-functional teams.

Qualifications

• 2+ years’ experience in biopharmaceutical operations or equivalent.
• Experience with aseptic processing/validation and facility/clean room design.
• Experience with internal and health authority audits.
• Excellent verbal and written communication.

Responsibilities

• Support execution of APS/APV and Validation activities and ensure manufacturing readiness.
• Author qualification/validation documents and ensure readiness for APS execution.
• Lead aseptic risk assessments and author associated summary reports.
• Author product impact assessments for Personnel and Environmental Monitoring-related deviations.
• Lead/own site Change Controls and support investigations and global changes.
• Contribute as SME to maintain cGMP compliance and support regulatory inspections.

Skills

cGMP compliance

Aseptic processing

Regulatory audits

Communication skills

Education

Bachelor’s degree in science/engineering/biochemistry

Job description

Shifts Available:

• Monday–Friday, Standard Working Hours

Responsibilities:

• Support execution of Aseptic Process Simulations/Validations (APS/APV) and Aseptic Performance Qualifications.


• Author qualification/validation documents (procedures, protocols, summary reports) and ensure Manufacturing readiness for APS execution.


• Participate in/lead aseptic risk assessments; author associated summary reports.


• Author product impact assessments for Personnel and Environmental Monitoring-related deviations.


• Lead/own site Change Controls as required; support investigations and global change controls as required.


• Ensure safe, compliant cGMP operations; maintain inspection readiness and support regulatory inspections as a Subject Matter Expert.


• Serve as an MS&T representative on cross-functional/multi-site teams and build collaborative relationships to influence product/process life cycle programs.

Knowledge & Skills:

• Experience with cGMPs and multinational biopharmaceutical/cell therapy regulations.


• Experience in aseptic processing/validation and facility/clean room design.


• Experience with internal and health authority audits.


• Excellent verbal and written communication.

Basic Requirements:

• Bachelor’s degree in science, engineering, biochemistry, or related field (or equivalent).


• Minimum 2 years’ experience in biopharmaceutical operations (or equivalent).

Compensation/Benefits (as listed):

• Devens, MA, US: $87,660–$106,224.


• Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability and life insurance; PTO options per employment type.