Sr. Engineer, Commissioning, Qualification, and Validation

BioSpace; Norwood (MA); Hybrid; USD 130,800 - 209,400; Full time

Benefits offered by this job

Best-in-class healthcare

Well-being resources

Family planning benefits

Generous paid time off

Retirement planning/savings

Location-specific perks

Job summary

ModernaTX, Inc. seeks a Senior Engineer for Commissioning, Qualification and Validation at its Norwood, MA facility. You will manage CQV activities for GMP manufacturing, ensuring validated status of facilities, equipment and processes, andOwn CAPAs and deviations while leading investigations and cross-functional teams.

The role requires a strong CQV background with IQ/OQ/PQ protocol writing and change control experience; telecommuting up to 30% is possible.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences or related life science field.
• 5+ years of post-baccalaureate experience in CQV/Validation in a cGMP environment.
• Experience writing IQ/OQ/PQ protocols and reports.
• Experience authoring validation-related Change Controls and Deviations.
• Ability to telecommute up to 30%.

Responsibilities

• Manage commissioning, qualification and validation activities for a GMP manufacturing facility.
• Ensure validated status of facilities, utilities, equipment and processes.
• Track metrics for re-qualification programs and report to stakeholders.
• Own quality records including Change Controls, Deviations, CAPAs, and improvements.
• Lead investigations related to manufacturing equipment, utilities, automation and systems.
• Provide validation SME support for equipment, systems and analytical instruments.
• Participate in cross-functional teams to meet project timelines.
• Support continuous quality system improvements within CQV and Change Control programs.
• Review contractor deliverables and manage priorities; drive validation initiatives.
• May telecommute up to 30%.

Skills

IQ/OQ/PQ Protocols

CQV Engineering

cGMP Manufacturing

CAPA Deviations

Regulatory Compliance

Education

Bachelor’s degree in Pharmaceutical Sciences or related life science

Job description

The Role:

ModernaTX, Inc. seeks a Sr. Engineer, Commissioning, Qualification, and Validation for its Norwood, Massachusetts location.

Here’s What You’ll Do:

• Manage the commissioning, qualification, and validation activities for the company’s Good Manufacturing Practices (GMP) manufacturing facility.
• Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance and standards.
• Track and report status on metrics relevant to the re-qualification program activities and responsibilities, and ensure commitments to key stakeholders are met.
• Own quality records such as Change Controls, Deviations, Corrective and Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities.
• Lead investigation and review deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Provide validation subject matter expertise and support for equipment and systems in use, including Controlled Temperature Units such as Refrigerators, Freezers, Incubators; Analytical Instruments used for in-process and quality control testing; and Manufacturing Unit Operations including Ultrafiltration, Chromatography, Mixers, Tanks and Vessels, and Bioreactors and Fermenters, among others.
• Participate in multi-functional department teams for validated process, equipment, utilities, method, and computer systems, to meet established timeframes for project implementations that support business needs and meet global regulatory requirements.
• Participate in continuous quality system improvements and support implementing improvements in the GMP Validation and Change Control Programs.
• Review deliverables by contractors and consultants in the day-to-day execution of Commissioning, Quality and Validation (CQV) scope, and manage contractor priorities.
• Drive results by owning and completing validation initiatives and projects against identified timelines.
• May telecommute up to 30%.

Minimum Requirements:

Here’s What You’ll Bring to the Table:

• Requires at least a Bachelor’s degree in Pharmaceutical Sciences or related life science field and 5 years of progressive post-baccalaureate experience in the position offered or as Senior Validation Engineer, Validation Engineer, CQV Engineer or related position in a cGMP manufacturing environment.
• 5 years of experience must include:
• Writing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocols and Reports;
• Authoring Validation-related Change Controls, Deviations, and Investigations;
• Executing Validation activities across various projects;
• Applying Continuous Improvements to periodic review and requalification programs; and
• Applying manufacturing equipment knowledge to understand and develop testing requirements.
• May telecommute up to 30%.

The salary range for this role is $130,800 to $209,400. This range reflects the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting. The minimum target pay for this particular position, based on its primary location, is $170,000 to $209,400. An individual’s placement within the range will depend on several factors, including but not limited to specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras

The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.