Process Validation Associate
1 Antibody Way Oceanside, CA 92056
Bayside Solutions is seeking a Process Validation Associate to be part of our client’ s team in Oceanside. 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.
Process Validation Associate
- 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:
- Assist with PV document reviews for Process Engineering
- Manage document review workflows
- Facilitate communications with authors and document approvers to ensure adherence to PV document schedule
- Optimize document review functionality into existing MSAT SharePoint intranet site
- Assist with process validation sampling
- Train on the process validation sample request process
- Submit PV sample requests to manufacturing per the PV schedule and PV sampling plan; communicate all special sample requirements and ensure appropriate sample containers are available
- Aliquot, label and freeze PV samples within specified hold time
- Ship PV samples to analytical support labs
- Facilitate the transfer of data to study authors
- Assist with large and small-scale studies to support process validation and tech transfer
- May include: cell culture, chromatography, filtration, analytical, or mixing studies
- All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA)
- Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’ s functional area. Fosters a positive safety culture in which no one gets hurt.
- May act as Subject Matter Expert for the purposes of training S&E personnel
- Embraces open communication, teamwork and transparency by aligning efforts and knowledge sharing
Summary of Qualifications:
- Bachelor' s or Master' s degree in Engineering or Life Sciences.
- 4-6 years experience in relevant field.
- 2-4 years experience with Master
- Experience with Microsoft SharePoint
- Proven management, communication, interpersonal, organizational and project management skills.
- Demonstrated ability to work as part of a multi-disciplinary team.
- Ability to interact within and across work groups and with outside collaborators and vendors on technical matters.
- Demonstrated technical proficiency
- Practical and theoretical expertise in biopharmaceutical manufacturing processes engineering and applied technologies.
- Strong oral and written communication skills.
- Work in office and, to a lesser extent, laboratory environment.
- May be on feet for 4 to 5 hours a day.
- Lifting up to 25lbs may be required.
- May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment.
- May work with hazardous materials and chemicals.