Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.
Validation Engineer
Valspec is the leading provider of computer system validation services in the greater Philadelphia area. We specialize in validating Emerson technology, including the Emerson DeltaV distributed control system and Syncade manufacturing execution system. Our team of experts ensures that our clients' systems meet regulatory requirements and operate efficiently to support their critical processes.
Job Description:
As a Validation Engineer at Valspec, you will play a crucial role in ensuring the compliance and reliability of our clients' computer systems, particularly those utilizing Emerson technology. You will work closely with clients to understand their validation needs and execute validation activities to meet regulatory standards and industry best practices.
Key Responsibilities:
- Conduct validation activities for computerized systems, with a focus on Emerson DeltaV distributed control systems and Syncade manufacturing execution systems.
- Develop and execute validation protocols, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Perform risk assessments and develop validation strategies to mitigate potential risks associated with computerized systems.
- Collaborate with clients, project managers, and other stakeholders to ensure alignment of validation activities with project timelines and objectives.
- Generate validation documentation, including protocols, reports, and deviations, in accordance with regulatory requirements and company standards.
- Provide technical expertise and support to clients during regulatory inspections and audits.
- Stay current with industry trends, regulatory guidelines, and advancements in Emerson technology to continuously improve validation processes and methodologies.
Qualifications:
- Bachelor's degree in Engineering, Computer Science, or related field.
- Minimum of 2 years of experience in computer system validation.
- Proficiency in validation principles, methodologies, and regulatory requirements (e.g., FDA, GAMP 5).
- Strong understanding of Emerson DeltaV distributed control systems and Syncade manufacturing execution systems.
- Excellent analytical and problem-solving skills, with the ability to identify and mitigate risks associated with computerized systems.
- Effective communication skills, both verbal and written, with the ability to interact professionally with clients and team members.
- Detail-oriented mindset with a commitment to producing high-quality validation documentation.
Benefits:
- Competitive salary commensurate with experience
- Comprehensive health, dental, and vision insurance plans
- Retirement savings plan with employer matching
- Paid time off and holidays
- Professional development opportunities to enhance skills and knowledge in computer system validation and Emerson technology.
Join Valspec and be part of a dynamic team dedicated to ensuring the compliance and reliability of computerized systems for our clients in the greater Philadelphia area. Apply now to contribute your expertise to our mission of delivering premier validation services.
Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, and other unique incentives.
Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.
Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.
Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
