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Validation Engineer
1 week ago
Draft, review, author, and deploy all required validation documentation including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, URS, FRS, and so on.
Provide technical expertise throughout the validation lifecycle including risk assessment, deviation investigation, and change control activities.
Support environmental monitoring tasks as required.Effectively identify potential risks and areas of improvement and proactively implement risk mitigation.
Document test results, deviations, and investigations in compliance with company procedures and regulatory standards.
Collaborate with cross functional teams to support all project timelines and deliverables, and be able to drive successful validation of critical systems and equipment.
Contribute to the continuous improvement of validation processes and procedures.
Ensure compliance with industry regulations and requirements at all times.
Additional responsibilities as required.
Requirements
Bachelor's degree in related engineering discipline.
3-7 years of experience executing commissioning, qualification, and validation for a range of equipment within the pharmaceutical and/or medical device industries.
Strong knowledge of regulatory requirements (cGMP, FDA, etc.).
Excellent problem-solving, analytical, and technical skills. Ability to problem-solve and troubleshoot effectively.
Strong time management and organizational abilities.
Effective communication and interpersonal skills.
Detail-oriented mindset with a commitment to maintaining high-quality standards.
Ability to work independently and as part of a team.
Benefits
Medical Benefits
Sick Time
Equal Opportunity Employment Statement:PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs,
including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.#LI-RW1RequirementsBachelor's degree in related engineering discipline. 3-7 years of experience executing commissioning, qualification, and validation for a range of equipment within the pharmaceutical and/or medical device industries. Strong knowledge of regulatory requirements (cGMP, FDA, etc.). Excellent problem-solving, analytical, and technical skills. Ability to problem-solve and troubleshoot effectively. Strong time management and organizational abilities. Effective communication and interpersonal skills. Detail-oriented mindset with a commitment to maintaining high-quality standards. Ability to work independently and as part of a team.
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