Senior CQV Engineer

Pharmatek Consulting•Austin, TX

60d•Onsite

About The Position

You will be responsible for performing quality oversight & approval of validations, change controls, records, & projects to ensure consistent deliver of high quality documents, processes, products, and processes. This position is responsible for providing quality support and oversight on product, process, and equipment related changes and implementations (validation & change control). Specifically, Provide quality support and oversight (approval) of process and equipment validation and change control records and activities, Ensure that facilities, utilities, and equipment (FUE) used in the support of the Quality System are validated and maintained in compliance with regulatory and client requirements, Review documentation (e.g. validation records/reports, change control records, periodic reviews, etc.) for accuracy, clarity, consistency, completeness, and compliance, Plan and complete assignments with a wide degree of difficulty while maintaining milestones established in the project schedule, Analyze data, procedures, and requirements to ensure quality and compliance, Collaborate with alternate functional teams (including but not limited to engineering, operations, regulatory, program management, and other quality teams) to ensure consideration is given to financial and business outcomes when making quality decisions. Coordinate activities across multiple project groups, Accept ownership and responsibility for decisions, Effectively engage with team members within client and third party manufacturer (TPM) teams, and Provide leadership, guidance, coaching, and training to various functions and colleagues.

Requirements

Bachelor's Degree in Engineering or Technical Field or an equivalent combination of education and work experience
Minimum 5 years experience in medical device/pharmaceutical manufacturing
Process Validation experience and demonstrated use of Quality tools/methodologies.
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
Strong project management and leadership skills, including the demonstrated ability to lead multi -departmental project teams and resolve quality -related issues in a timely and effective manner
Ability to work within a team and as an individual contributor in a fast -paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Ability to maintain regular and predictable attendance

Nice To Haves

Prior medical device validation experience preferred.
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

Responsibilities

Participate in the development or modification of validation packages and deliverables, including assessments, plans, requirements, and protocols.
Report unexpected events or issues which occur during validation to project team and management.
Apply sound, systematic problem -solving methodologies in identifying, investigating, assessing impact, and resolving unexpected events or issues which occur during validation.
Perform quality oversight & approval of equipment, process, and validation documentation and change control records (e.g. pFMEAs, URSes protocols, reports, SOPs, work instructions, process flow diagrams, ECs, etc.)
Review documentation for accuracy, clarity, consistency, completeness, and compliance to internal and external requirements for multiple projects
Drive strategy of FUE & process validation for new or changing products, processes, facilities, equipment, etc.
Ensure that appropriate procedures, controls, and recovery plans are incorporated into equipment, system, process, and/or product implementations/changes.
Work with cross functional teams to ensure quality and compliance requirements are considered during activities (e.g., work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities)
Drive to meet validation schedule as aligned with project(s) goals.
Works independently with objectives given by the Quality Manager.
Plan and coordinate own work according to higher level project schedules.
Support (as needed) the investigation, resolution and prevention of product and process non conformances, CAPA investigations, or other quality system records.
Identify areas for process improvement and provides supporting information for change, including reasons and justifications.
Assist team members and cross functional colleagues in meeting their goals by providing coaching and mentoring as needed.
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
Support projects and Divisional initiatives as identified by management.
Performs other related duties and responsibilities, on occasion, as assigned.