Validation Specialist

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

The opportunity:

• Prepare and execute Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols for manufacturing, utility, and laboratory equipment.

• Collaborate with cross-functional teams, including Engineering, Quality, Operations, and Vendors, to complete validation deliverables.

• Perform risk-based qualification assessments and support commissioning and prequalification activities.

• Develop and maintain validation documentation according to Good Documentation Practices (GDP) and internal procedures.

• Ensure compliance with cGMP, FDA, ISO 13485, and relevant corporate policies throughout all validation activities.

• Apply project management tools to track validation timelines and communicate risks, delays, or required support.

• Support continuous improvement initiatives within the validation function to enhance efficiency, compliance, and consistency.

• Participate in audits and regulatory inspections as needed.

• Contribute to team development by mentoring or cross-training peers when required.

• Perform other duties as assigned by management.

Who you are:

Education and Training

• Bachelor's degree in Engineering, Life Sciences, or a related field (required).

Knowledge, Skills, and Abilities

• 1-4 years of experience in GMP-compliant lab environments within the biotech, pharmaceutical, diagnostics, or medical device industry (required).

• Hands-on experience in equipment and facility validation, including protocol development, execution, and lifecycle documentation (preferred).

• Solid understanding of cGMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, Annex 11, and ISO 13485.

• Familiarity with Design Control Guidelines and process validation principles (preferred).

• Understanding of assay, reagent, and instrument manufacturing and tools used in technology transfer and validation.

• Proficiency in Google Workspace (Docs, Sheets) and Microsoft Office (Word, Excel, PowerPoint); experience with Minitab and SAP is a plus.

• Experience with continuous improvement, Lean, or Six Sigma methodologies is desirable.

• Strong technical writing and communication skills, with the ability to generate high-quality documentation.

• Proven ability to prioritize and manage multiple projects while meeting deadlines in a fast-paced environment.

• Demonstrated ability to work independently and collaboratively in cross-functional teams.

• Team-oriented with a willingness to mentor, cross-train, and support team members.

Certifications (Preferred but not required)

• ASQ Certified Quality Engineer (CQE)

• ISPE Certified Pharmaceutical Industry Professional (CPIP)

Relocation benefits are not available for this job posting.

Grade level: SE4

Pay transparency

The expected salary range for this position based on the primary location of

Branchburg is 63,100.00 - 117,100.00 USD Annual.Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.A discretionary annual bonus may be available based on individual and Company performance.This position also qualifies for the benefits detailed at the link provided below.

Benefits

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.