Title: Process Engineer Duration: 18 Months Location: Andover, MA
POSITION SUMMARY: The engineer/scientist in manufacturing Support operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development drug substance. Additional roles include using operational and technical knowledge to lead, oversee, and evaluate troubleshooting activities, tech transfer and start-up activities, investigations, analyze/interpret process data, and identify and implement complex process improvements.
Roles and Responsibilities: • Contribute to the completion of projects and manage own time to meet agreed targets. • Understand the fundamental business drivers for the Client and make decisions within organization's guidelines and policies. • Serve as technical support within your assigned group, collaborating with outside groups as needed. • Serve as the operations point of contact for campaign start-up CC, site assessment, impact assessment, generation of cGMP documentation, area preparation and summary reporting. • Audit Support during audits, ensuring smooth communication and providing necessary support and prepare comprehensive responses to audit findings, addressing each point with clarity and accuracy. • Oversee Corrective and Preventive Actions (CalOOTs), ensuring timely implementation and effectiveness. • Facilitate and initiate change control processes, including PTCs and EM-PTCs. • Collaborate with other departments to address corrective actions stemming from audits, inspections. • Conduct risk assessments and participate in revisions to ensure continuous improvement in compliance efforts. • Provide support for Quality Assurance Reviews (QAR) and Corrective and Preventive Action (CAPA) plans, ensuring compliance and effectiveness. • Lead and support in environmental and facility compliance activities, ensuring adherence to regulations and company standards. QAC Requests, CAS Reports to PQS Revisions • Analyze control deviations across multiple products and provide insights to the Site Quality Review Team (SQRT). • Facilitate and Conduct training sessions. • Monitor safety protocols and procedures on a day-to-day basis to maintain a safe working environment. • Prepare the manufacturing site for inspections by regulatory agencies through thorough walkthroughs and readiness assessments. • Conduct compliance walkthroughs for Manufacturing Operations (MamOps) suites to identify and address any non-compliance issues. • Revising technical documents related to compliance, ensuring accuracy and alignment with current regulations. • Support procurement and validation of new equipment and technologies for impact assessment. • Conduct skills training and provide subject matter expertise for training materials.
Qualifications: Must-Have • Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience • OR an associates degree with 6 years of experience • OR a bachelors with at least 2 years of experience • OR Masters with more than 0-1 year of experience. • Good verbal communication and ability to coach and provide guidance to others. • Computer literate, with skills in Microsoft Applications and process tracking software. • Able to work individually and in a team environment. Nice-to-Have • Master’s degree and relevant pharmaceutical experience • Continuous Improvement or Project Management Certifications. • Previous experience in a GMP manufacturing environment. • Familiarity and experience with mammalian cell culture, centrifugation and ultrafiltration.
PHYSICAL/MENTAL REQUIREMENTS: Work will include walking throughout the manufacturing suite including up and down stairs. An ability to cross reference multiple documents and perform a detailed review of documentation is required.
EDUCATION AND EXPERIENCE: • BA/BS in chemical engineering, biology, biochemistry or related science or engineering field. Minimum of 4+ years relevant experience with an engineering degree or, MS +3 yrs. • Good verbal communication and ability to coach and provide guidance to others. • Computer literate, with skills in Microsoft Applications and process tracking software. • Able to work individually and in a team environment.
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. 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: $24.47/hr.