Process Engineer IV

Job title: Process Engineer IV

Duration: 1 Year

Location: Framingham, MA 01701 (Fully Onsite role)

Shift

1st

Work Schedule

9-5 EST Mon-Fri (Fully onsite role)

HM Notes:

Must have strong downstream manufacturing experience.

Lab support and majority of time will support manufacturing.

Process Engineer Role - open to candidates willing to at their own expense - Possibility of an extension, TBD, Free parking onsite Some OT may be required, possible weekends, Slight flexibility with work hours

Must have:

Direct Commercial manufacturing support experience

Previous pharma or biotech experience

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

Strong communication skills, position will interface with multiple departments.

Direct Commercial manufacturing exp

This team is providing technical expertise to Quality, Manufacturing, etc. all departments. S

trong understanding of GMP environments, deviations, CAPA's

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

DEPARTMENT DESCRIPTIONS

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.

KEY 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.

BASIC 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

LEADERSHIP QUALIFICATIONS

N/A

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

Applicant Notices & Disclaimers

For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $85.00/hr.