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PSC Biotech Corporation ยท 2 days ago
Validation Engineer
Milwaukee, WI
Full-time
Onsite
Mid Level
3+ years exp
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Responsibilities
Lead the development and execution of commissioning, qualification, and validation protocols for a range of equipment and systems.
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.
Qualification
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Required
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
Company
PSC Biotech Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
201-500 employees
H1B Sponsorship
PSC Biotech Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (2)
2022 (4)
2021 (7)
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
John Clapham
Founder, President & CEO
Company data provided by crunchbase
