Job Description

Job title: Process Engineer IV

Location: Framingham, MA (01701)

Duration: 12 Months

This position's starting pay is: $84.00/hr.

Work Schedule

9-5 EST Mon-Fri

HM Notes:

Manufacturing support and 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:

• 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.

• This team provides technical expertise to Quality, Manufacturing, etc. all departments.

• Strong understanding of GMP environments, deviations, CAPA’s

PREFERRED QUALIFICATIONS

• Demonstrated expertise in 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 extractable.

• Understand the cGMP concept and be familiar with the quality and regulatory framework.

• Proficient in process data analytics

• Knowledge of computerized systems in a 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. • Strong communication and technical writing skills

Description:

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

About Us: Established in 2004, SPECTRA FORCE ® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRA FORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at:

Benefits: SPECTRA FORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRA FORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRA FORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.

California Applicant Notice: SPECTRA FORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.

LA County, CA Applicant Notice: If you are selected for this position with SPECTRA FORCE , your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.

At SPECTRA FORCE , we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.

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