usa-scientist iii (scientific).

job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

 
location: Framingham, Massachusetts
job type: Contract
salary: $85.00 - 88.77 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Manufacturing Science is a partner of biologics manufacturing operations and is the custodian of manufacturing processes. Manufacturing Science ensures manufacturing processes are capable, compliant, in control, cost effective, and continuously improved.

- Provide collocated technical leadership at manufacturing sites including process monitoring, CPV, root cause investigation, change assessment, debottlenecking, and continuous improvement

- Anticipate, respond to, and permanently resolve issues that arise during production.

- Aid in design of new processes and facilities with expertise in scale up, manufacturability, PAT, capacity analysis, and cost analysis.

- Lead the creation and use of digital process data analytic systems.

- Partner with internal and external functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements.

Job Responsibilities

The Process Engineer IV role is expected to

- Provide technical leadership in area of responsibility. Provide technical/scientific support, expertise, and guidance to manufacturing and quality.

- Ensure a solid understanding of engineering principles and theories in the area of responsibility and uses them to solve a range of complex problems in creative and practical ways.

- Lead technical project team or cross-functional team between groups/organizations. Provide input and coordinates support from process development teams.

- Review manufacturing processes and/or development and production data.

- Design and conduct necessary experiments; contributes to understanding and interpretation of results; recommend changes or additional experiments.

- Support documentation preparation for regulatory purposes and stay current on regulatory requirements that have impact on manufacturing processes and evaluate/implement changes if required.

- Provide CMC support and guidance for product life cycle management.

- Attend trainings and scientific meetings to remain current with technology and regulatory guidelines.

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

 
qualifications:
- Bachelor's Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 7 years of relevant experience in the biopharmaceutical or pharmaceutical related industry

OR

- Master's Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 5 years of relevant experience in the biopharmaceutical or pharmaceutical related industry

OR

- Doctor's Degree in Chemical or Biochemical Engineering, or related engineering disciplines with 3 years of relevant experience in the biopharmaceutical or pharmaceutical related industry

PREFERRED QUALIFICATIONS

- Demonstrated expertise applying fundamental principles to real world problem solving and providing practical solutions to difficult technical issues.

- Experience with biologics downstream unit operations, Filtration, UF/DF, Chromatography, Viral clearance, and leachable and extractables.

- Understand cGMP concept and familiar with quality and regulatory framework.

- Proficient in process data analytics

- Knowledge of computerized systems in biopharmaceutical manufacturing environment, i.e., Distributed Control System, Process Data Historian, LIMS, and MES.

- Experience leading projects and/or cross functional teams.

- Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

- Ability to navigate ambiguous circumstance to meet final objectives.

- Strong communication and technical writing skills. Experience communicating with business partners and senior management.

SPECIAL WORKING CONDITIONS

- Ability to gown and gain entry to manufacturing areas

 
skills: Chromatography, Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.