Job Title: Manufacturing Engineer II Duration: 08 Months Location: Mansfield, MA 02048
Will this worker be part of a Special Project?
EUMDR
ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Maintain and Support new and existing Operations Equipment • Understand and be knowledgeable of Equipment and Process Operations completed in the facility. This includes, site SOPs, Equipment documentation, capacity, setup, operation, disassembly, maintenance, cleaning, troubleshooting, monitoring, and programming of manufacturing equipment and facility. • Perform testing and troubleshooting on equipment to determine functionality level and capacity. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to: • Create, update, and maintain equipment service work instructions. • Organize and write validation protocols associated with the manufacturing process • Lead and support troubleshooting activities to minimize process downtime or re-occurrence Identify key process indicators and collect data to drive manufacturing and yield improvements
Responsibilities:
Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices.
Provide statistical analysis of the date to support the reports.
Generation and implementation of change controls and engineering notices (ECO).
Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
Troubleshooting equipment/processes that do not perform as intended during validation runs. Recommend process/quality improvements as part of validation runs.
Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
Work on project teams with other internal departments, external vendors, and customers as required. Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others. Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others. Performs other related duties as necessary.
Qualifications:
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Knowledge in Organizational Excellence and Lean/Six Sigma. Strong Project Management skills.
Ability to lead teams through complex projects and provide departmental technical leadership.
Must have excellent communication skills and a strong track record of working cross-functionally.
Must have demonstrated ability to think strategically.
Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Teamwork oriented and self-starter.
Education and/or experience:
BS in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
Lean/Six Sigma Green or Black Belt Certification is a plus.
Experience in validations such as: manufacturing equipment, manufacturing processes, stability or aging, required.
?Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing 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.
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: $50.00/hr.
