Process Engineer/Scientist II
Spectraforce
Andover, Massachusetts
13 days ago
Job Description
Title:Process Engineer/Scientist II
Duration: 9 months (Possible extension)
Location:Andover, MA, 01810
1st shift 6am -6pm, rotating Onsite
Description:
Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in client’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
You will have knowledge of process equipment and systems and manufacturing operations with the primary responsibility to execute process and equipment operation activities during manufacturing operations. Due to your expertise in the manufacturing domain, you may participate in training for operational qualifications and assist the Team Lead or other team members as needed. You will conduct all activities in accordance with Company policies and standard operating procedures, client Values, and global regulatory guidelines, environmental guidelines etc.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your hard work and focus that will make client ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
• Contribute to completion of project milestones and organize own work to meet project task deadlines.
• Use operational and technical expertise to assist in troubleshooting activities, technology transfer and start-up activities.
• Monitor the technical documentation for the production and processes approval.
• Ensure all production equipment and systems are in compliance with {Current} Good Manufacturing Practices.
• Manage execution of relevant process activities by following established Standard Operating Procedures.
• Perform process monitoring and data analysis, and data preparation for presentation in several forums including project team meetings.
ROLE RESPONSIBILITIES
Capable of managing inter-departmental projects and performing relevant presentations.
• Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment to moderately complex process and equipment change controls to ensure a robust and capable solution.
• Individual will be expected to participate and drive in continuous improvement and innovation initiatives. Individual is expected to be an M1 lead.
• Individuals will be required to display multi-tasking skills.
Qualifications/Must-Have
• 2+ Bachelor's Degree
• Experience within the pharmaceutical industry
• Effective verbal and written communication skills
• Mechanical knowledge and the use of hand tools
Nice-to-Have
• Master’s Degree
• Demonstrated ability to train and coach others
• Experience with Six Sigma or other operational excellence programs
• In-depth knowledge of drug substance/drug substance intermediate manufacturing technology
PHYSICAL/MENTAL REQUIREMENTS
• Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
• Must have the ability to lift ~50 pounds.
• The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam and/or corrosive chemicals.
• The incumbent is required to attain detail knowledge of the operational equipment.
• The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
• The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.
About Us: Established in 2004, SPECTRAFORCE® 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. SPECTRAFORCE 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: http://www.spectraforce.com
Benefits: SPECTRAFORCE 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. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE 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: SPECTRAFORCE 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 SPECTRAFORCE, 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 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: $47.00/hr.
Duration: 9 months (Possible extension)
Location:Andover, MA, 01810
1st shift 6am -6pm, rotating Onsite
Description:
Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in client’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve
You will have knowledge of process equipment and systems and manufacturing operations with the primary responsibility to execute process and equipment operation activities during manufacturing operations. Due to your expertise in the manufacturing domain, you may participate in training for operational qualifications and assist the Team Lead or other team members as needed. You will conduct all activities in accordance with Company policies and standard operating procedures, client Values, and global regulatory guidelines, environmental guidelines etc.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your hard work and focus that will make client ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
• Contribute to completion of project milestones and organize own work to meet project task deadlines.
• Use operational and technical expertise to assist in troubleshooting activities, technology transfer and start-up activities.
• Monitor the technical documentation for the production and processes approval.
• Ensure all production equipment and systems are in compliance with {Current} Good Manufacturing Practices.
• Manage execution of relevant process activities by following established Standard Operating Procedures.
• Perform process monitoring and data analysis, and data preparation for presentation in several forums including project team meetings.
ROLE RESPONSIBILITIES
Capable of managing inter-departmental projects and performing relevant presentations.
• Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment to moderately complex process and equipment change controls to ensure a robust and capable solution.
• Individual will be expected to participate and drive in continuous improvement and innovation initiatives. Individual is expected to be an M1 lead.
• Individuals will be required to display multi-tasking skills.
Qualifications/Must-Have
• 2+ Bachelor's Degree
• Experience within the pharmaceutical industry
• Effective verbal and written communication skills
• Mechanical knowledge and the use of hand tools
Nice-to-Have
• Master’s Degree
• Demonstrated ability to train and coach others
• Experience with Six Sigma or other operational excellence programs
• In-depth knowledge of drug substance/drug substance intermediate manufacturing technology
PHYSICAL/MENTAL REQUIREMENTS
• Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
• Must have the ability to lift ~50 pounds.
• The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam and/or corrosive chemicals.
• The incumbent is required to attain detail knowledge of the operational equipment.
• The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
• The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.
About Us: Established in 2004, SPECTRAFORCE® 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. SPECTRAFORCE 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: http://www.spectraforce.com
Benefits: SPECTRAFORCE 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. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE 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: SPECTRAFORCE 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 SPECTRAFORCE, 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 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: $47.00/hr.