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.
Lead Validation Engineer - Siemens Opcenter MES
Company:
Valspec
Location:
Los Angeles, CA (Travel costs covered for candidates outside of the LA area)
Employment Type:
Long-term
Valspec is a premier provider of validation and compliance services for computer systems in life sciences environments. Our mission is to ensure the highest standards of quality and reliability in the systems that drive life sciences manufacturing. We are dedicated to innovation, excellence, and continuous improvement, making us a trusted partner for leading organizations in the industry.
Position Overview:
We are seeking a highly skilled and experienced Lead Validation Engineer specializing in Siemens Opcenter MES to join our dedicated team. The ideal candidate will have a strong background in life sciences manufacturing and a proven track record in leading validation projects. This is a long-term opportunity based in the Los Angeles area, with all travel expenses covered for candidates residing outside of the region.
Key Responsibilities:
- Lead the validation of Siemens Opcenter MES solutions in life sciences manufacturing environments, ensuring compliance with regulatory requirements and industry standards.
- Develop and execute comprehensive validation plans, protocols, and reports for MES systems.
- Oversee the execution of validation activities, including IQ/OQ/PQ, data integrity assessments, and risk assessments.
- Collaborate with cross-functional teams, including engineering, quality, and operations, to ensure successful project outcomes.
- Provide technical guidance and mentorship to junior validation engineers and other team members.
- Troubleshoot and resolve validation-related issues, ensuring minimal impact on manufacturing operations.
- Maintain detailed and accurate documentation of all validation activities and system changes.
- Stay current with industry trends and best practices in MES validation and life sciences regulations.
Qualifications:
- Bachelor’s degree in Engineering, Computer Science, or a related field.
- Extensive experience as a Validation Engineer with a focus on Siemens Opcenter MES in life sciences manufacturing.
- Strong leadership skills and experience managing validation projects and teams.
- In-depth knowledge of validation principles, practices, and regulatory requirements in the life sciences industry.
- Excellent problem-solving abilities and attention to detail.
- Effective communication and interpersonal skills, with the ability to work collaboratively with diverse teams.
- Willingness to travel as needed for project requirements.
What We Offer:
- Competitive salary and comprehensive benefits package.
- Opportunities for professional growth and leadership development within a leading validation and compliance firm.
- Supportive and collaborative work environment that values innovation and excellence.
- Coverage of all travel expenses for candidates outside the Los Angeles area.
How to Apply:
Join Valspec and lead the way in ensuring the highest standards of quality in life sciences manufacturing. Apply today!
Join Us:
Salary Range: $100000 - $125000 / year salary range is an estimate of pay for project-based employment. Range varies based on knowledge and experience. Higher rates for short-term assignments and independent contractors. If you are a dedicated Validation Engineer with a passion for ensuring the quality and compliance of manufacturing processes in the biopharmaceutical industry, we want to hear from you! Join us on our mission to revolutionize medicine and transform lives. Apply now to be part of a dynamic team driving innovation in California and beyond.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.
