Lead Validation Engineer

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 Computer System Validation Engineer
Location: Remote
Duration: 1-year Contract (Full-time with benefits, potential for extension)
Position Overview:
As the Lead Computer System Validation Engineer, you will take on a pivotal role in spearheading the management of CSV (Computer System Validation) deliverables for new systems and existing applications within the life sciences manufacturing setting. Your expertise will be crucial in ensuring compliance with industry standards and regulatory requirements, ultimately contributing to the safety of patients.
Key Responsibilities

• Lead the management of CSV deliverables for new systems and existing applications, categorizing GxP and non-validation-requiring systems (NO GMP).
• Oversee and author advanced CSV documentation, including Initial System Assessments, Functional Specifications, Risk Assessments, Design Documents, SOP Planning, Data Integrity Assessments, Traceability Matrices, and various validation protocols (IQ, OQ, PQ), as well as Interim Memos and Validation Summary Reports.
• Collaborate with business units to develop strategic User Requirements, SOPs for administrative tasks related to applications, and protocols for deviations, ensuring compliance with regulatory standards.
• Act as a subject matter expert for a variety of systems, including Werum PAS|X, OSM (Optel Serialization), Oracle, Tracelink, Rockwell FactoryTalk, OSI/AVEVA PI, Siemens Desigo, LIMS, Empower, Veeva, ValGenesis, and other similar systems commonly used in the pharmaceutical industry.

Qualifications:

• Bachelor's or Master's degree in Computer Science, Engineering, or a related field.
• Proven experience in leading the management of CSV deliverables for GxP applications and NO GMP systems in the pharmaceutical or biotechnology industry.
• In-depth knowledge of regulatory requirements (e.g., FDA 21 CFR Part 11) and industry standards related to CSV.
• Strong analytical, problem-solving, and communication skills, both written and verbal.
• Ability to work both independently and collaboratively in a team-oriented environment.

Preferred Qualifications:

• Extensive experience with a range of validated systems such as Werum PAS|X, OSM (Optel Serialization), Oracle, Tracelink, Rockwell FactoryTalk, OSI/AVEVA PI, Siemens Desigo, LIMS, Empower, Veeva, ValGenesis, among others.
• Demonstrated expertise in authoring, developing, and reviewing complex CSV documentation and protocols.

Benefits of Contract Role:

• Competitive compensation with an hourly range of $65 - $90.
• Full-time role with benefits and the potential for contract extension.
• Valuable exposure to the biotechnology/pharmaceutical industry and its leading-edge research.
• Opportunities to play a strategic role in ensuring regulatory compliance through meticulous computer system validation practices.

How to Apply:
If you are a seasoned Lead Computer System Validation Engineer enthusiastic about leveraging your expertise in the pharmaceutical or biotechnology industry, please submit your resume. We are eager to review your application and potentially welcome you to our team.
Note: The hourly range is an estimate of pay for project-based employment, and we have 3 openings on this team.
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.