myGwork - LGBTQ+ Business Community · 3 days ago
Engineer III, Validation
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Responsibilities
Leads, schedules, and completes multiple projects of high complexity with multi-disciplinary departments to ensure accurate completion of results.
Serves as principle/validation liaison for collaborating with clients on agreements/projects and resolution of significant validation, product, and regulatory issues!
Coordinates, reviews, and prepares customer audit responses and reports.
Authors, performs reviews, and approves production, validation, protocols, and reports and/or procedures, and rationales!
Author validation plans; assist with the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ.
Review commissioning, qualification, and validation related system lifecycle documentation and design specifications, commissioning, and qualification protocols).
Assist with direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment.
Identify protocol discrepancies from established product or process standards and provide recommendations for resolving protocol discrepancies.
Analyze validation test data to resolve whether systems or processes have met validation acceptance criteria or to identify root causes of production problems.
Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to resolves deficiencies and take appropriate actions.
Defends policies, procedures, rationales, and methods in the area(s) of expertise during regulatory and client audits.
Additional responsibilities assigned as needed by manager.
Qualification
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Required
Bachelor's degree in engineering or Biological science related field preferred
5 years experience in CQV (Commissioning, qualification and validation)
Meaningful work experience in the pharmaceutical or a regulated industry, is preferred
Ability to work in a fast-paced environment with multi-tasks
Effective time management and prioritization skills
High degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle critical matters
Highly effective verbal and written communication skills
Benefits
EEO/Affirmative Action Employer
Accessibility services for job seekers with disabilities
Company
myGwork - LGBTQ+ Business Community
myGwork is the largest global platform for the LGBTQ+ business community.
Funding
Current Stage
Early StageTotal Funding
$4.77MKey Investors
24 HaymarketInnovate UK
2023-08-17Series Unknown· $1.66M
2023-08-17Grant· Undisclosed
2021-12-07Series A· $2.12M
Recent News
2024-04-10
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