1080 U.S. Highway 202 Branchburg, NJ 08876
Bayside Solutions is seeking a Technical Writer to be part of our client’ s team in the New Jersey area. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- This position is responsible for validation activities in a cGMP /CBER regulated medical device manufacturing environment.
- As a member of the Design Transfer and Technical Support Team, this position will participate in Process Validation activities including preparation of validation documents such as protocols, final reports and plans.
- This candidate will be responsible for preparing, reviewing and/or approving validation documents to support new product launches and any changes to existing validated processes for regulated on-market products.
- These validations may include the manufacturing and filling processes for bulk reagents (large and small scale) and for production intermediates such as Oligonucleotides, Control Stocks and Enzymes.
- Duties include the preparation of validation plans, protocols and reports, analysis of data, and developing validation strategies in accordance with industry guidelines and SOPs.
- This position must be able to lead validation deliverables / projects, manage multiple competing timelines and priorities and work in a cross-functional team.
Summary of Qualifications:
- Bachelor’ s degree in science, engineering or related field, or equivalent combination of education and work-related experience, required.
- Master’ s degree, preferred
- 1-3 years experience in manufacturing, preferably in a biotech or diagnostic equipment industry, required.
- 3-5 years experience in manufacturing, preferably in a biotech or diagnostic equipment industry with validation experience, preferred
- Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought.
- Demonstrated troubleshooting and problem solving skills including the use of designed experiments.
- Strong teamwork and communication skills.
- Experience with Microsoft Office, MiniTab and statistical analysis and PCR technology, preferred.