Branchburg is the molecular diagnostics manufacturing engine within Global Operations and a Polymerase Chain Reaction (PCR) center of excellence. As the largest DIA manufacturing site in North America, our teams deliver a broad portfolio of PCR-based in-vitro diagnostic tests. Our operations include reagent and active diagnostic ingredient (ADI) production, filling and packaging. Our 63-acre site with ~1400 people is currently under expansion, fueled by our culture of agility, innovation and transformation. Each day we focus on delivering the value of Roche Diagnostics to patients around the world.

Responsibilities:

• Perform equipment Installation, Operational, and Performance Qualifications on a variety of facility, clean utilities, manufacturing process equipment, and analytical testing equipment in a full Biotech upstream/downstream manufacturing plant. Qualification includes conception of qualification assessments, protocols, authoring protocols, execution, and final report writing.

• Experience with filling/capping and secondary packaging lines including labeling is preferred. Experience with manufacturing equipment such as fermenters, process HPLC’s, analytical UPLC’s, and Spectrophotometers is preferred.

• Experience with facility equipment such as water, clean steam, clean compressed dry air, and nitrogen systems is desired. Additional facility equipment experience with autoclaves, walk in controlled temperature units, environmentally controlled areas, process control systems, and building management systems is also desired.

• Documents equipment/facility/utility qualification activities accurately and appropriately, and according to established formats and procedures.

• Provide solutions to technical issues and are responsible for meeting project timelines and ensuring the delivered solution meets the technical specifications and design requirements recognizing system or process deficiencies and implements effective solutions.

• Development of qualification or validation strategy that is robust and agile.

• Clear evidence of sustained independent thought and creativity in developing and implementing change.

• Exceptional record of successful and creative efforts contributing critically to the progression of multiple Projects.

• The candidate must be a self-starter with the ability to work with minimal supervision in a fast-paced environment. The candidate must have the ability to prioritize and manage multiple projects and priorities. The candidate must be a team player, willing to help others and cross train them as necessary.

Requirements:

• Bachelors Degree in Science or Engineering required, Master’s Degree preferred.

• At least 6 years of relevant experience required.

• Equivalent combination of education and work experience will be considered.

• Experience in assay optimization, experimental design, versatile laboratory practice, data analysis, and data and concept presentation.
  

Relocation benefits are not available for this job posting.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company’s health and safety obligations and/or applicable law or guidelines.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com.