Validation Program Manager Jobs

- Develop and maintain validation schedules, work with internal and external partners to manage schedule risks and mitigations.

Working knowledge of electrical or mechanical engineering

Experience working with suppliers in Asia

Job Title: Validation Program Manager

Location:– Remote (California, Washington, Oregon)

Not Required but good to have skills:

Proven leadership and team management experience is essential.

Exceptional problem-solving and project management skills are expected.

Oversees the qualification of manufacturing equipment, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

The Validation Manager should hold a bachelor's degree in engineering or a related field, with an advanced degree preferred.

They should have a minimum of [7] years of experience in validation within the medical device or pharmaceutical industry.

The Validation Manager should be detail-oriented with a focus on documentation and compliance.

3 years experience in Quality Management

Actively manage project validation and design quality engineering teams for successful execution.

Navigate challenges between project execution and policy requirements for compliant outcomes.

Manage Validation program for Strategic Capacity Expansions, ensuring success of large-scale capital projects.

Assure team compliance with quality and regulatory standards, divisional, and local requirements.

Oversee approval of change processes and design control documentation to meet requirements.

Experience in the management and conduct of Validation activities as part of either a program or development program.

Self- starter with initiative and proven management skills

Tertiary degree in Aviation (Management), Engineering or equivalent experience.

Engage with Wisk partners (Boeing) to align FAA and Boeing initiatives to Wisk operational requirements.

5+ years experience in a Part 135 Airline. (Flight Operations / Dispatch)

Demonstrated experience with Autonomous aircraft

Experience in the management and conduct of Validation activities as part of either a program or development program.

Self- starter with initiative and proven management skills

Tertiary degree in Aviation (Management), Engineering or equivalent experience.

Engage with Wisk partners (Boeing) to align FAA and Boeing initiatives to Wisk operational requirements.

5+ years experience in a Part 135 Airline. (Flight Operations / Dispatch)

Demonstrated experience with Autonomous aircraft

Experience in the management and conduct of Validation activities as part of either a program or development program.

Self- starter with initiative and proven management skills

Tertiary degree in Aviation (Management), Engineering or equivalent experience.

Engage with Wisk partners (Boeing) to align FAA and Boeing initiatives to Wisk operational requirements.

5+ years experience in a Part 135 Airline. (Flight Operations / Dispatch)

Demonstrated experience with Autonomous aircraft

To be considered for this position, you will need the following skills, experience, knowledge, and attributes.

Liaise with Regulatory Affairs Manager to ensure all activities comply with QMS and regulatory requirements

Manufacturing and validation documentation authorship and approval responsibilities

Comply with regulatory requirements (including TGA, HC, FDA and IVDR)

Maintain of appropriate safety, record keeping and quality requirements

Experience in Product, Process or Equipment Validation of medical devices to FDA regulations

Demonstrated previous experience in problem solving, decision making, negotiating and conflict resolution skills

Implements unique approaches to problem solving. Independently manages increased levels of risk.

Relevant pharmaceutical experience (Quality Operations)

Demonstrated business acumen, experience in managing projects teams, programs, or workstreams of varying levels of complexity

Strong oral and written communication skills

Strong verbal and written English communications capabilities

5+ years of proven account management experience, preferably within health insurance or healthcare provider revenue cycle

Knowledge and experience in healthcare claims processing

Ability to adapt quickly learn use of payment integrity vendor management software applications

Experience and knowledge with healthcare claims payment integrity

Understanding of basic financial operations, invoicing and accounts receivable management

Communicate regularly with clients to understand operation needs, build mutual account knowledge and develop a trust relationship through demonstrated delivery consistency

Participates in the generation and/or update of validation master plans and reports status to management.

Minimum 10 years’ experience in biotech/pharma Validation projects or equivalent combination of education and experience.

Knowledge of EU/international and US cGMP regulations for pharmaceutical guidelines, manufacturing operations, metrology requirements, validation procedures and practices.

Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes.

Coordinate qualification and validation trials and testing.

Ensures test methods supporting qualification or validations are scientifically sound, formally documented, and validated or compendial, as applicable.

Able to resolve complex issues with minimal assistance from management. Represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits.

Interprets and understands complex data and forms conclusions and next steps based on findings with minimal assistance from management.

Anticipates issues and elevates them to appropriate management attention immediately.

Knowledge and experience in process and/or cleaning validation in a biopharmaceutical/pharmaceutical cGMP environment.

Experience with and knowledge of aseptic manufacturing procedures.

Provide guidance/coaching to less experienced colleagues.