Engineer, Manufacturing in Durham NC

Job Title: Engineer, Manufacturing
Location: Durham NC
Duration: Fulltime Perm role

Engineering /Manufacturing Operator is to perform all required Batch manufacturing, packing, equipment cleaning, area cleaning, in- process testing & sampling for Manufacturing and Packaging batches for Transdermal Products primarily and potentially Topical and Inhalation.

• MUST HAVE TRANSDERMAL, TOPICAL, OR INHALATION EXPERIENCE.
• Perform maintenance and troubleshooting of transdermal equipment and machinery.
• Perform verifications using special instruments (Caliper, Balance, etc.).
• Assist the Batch manufacturing, Packing & Cleaning of the equipment machinery and area.
• Assist all required In-process testing & sampling of batches in progress and products to be packaged.
• Assist Calibration of weighing and required equipment.
• Perform packaging activities.
• Handle various requests from departments for developmental or investigative reasons.
• Complete all applicable training forms in a timely manner and forward to document control for archival.
• Perform other duties as assigned.
• Hands on experience with transdermal product manufacturing equipment is a must
• Familiar with proper documentation and correction practices.
• Read, write and speak English REQUIRED.
• Knowledge of transdermal product manufacturing machine adjustments during set up, operation, troubleshooting, cleaning before & after use.
• Knowledge of weights, scales & measures, experience of handling measuring equipment/instruments.
• Must be a team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, Warehouse, Engineering and Supply Chain to meet finished product release goals.
• Be able to work long hours to support production requirements with flexibility to rotate 1st, 2nd or 3rd shift.
• Be available for overtime, including weekends, as needed for production support.
• Possess the ability to analyze information and make consistently good decisions.
• A familiarity with cGMPS, CFRs, OSHA and FDA regulations.
• Knowledge of deviations/incidents and CAPA.

• High School Diploma with some college courses, Associates Degree.
• Up to 3 years of experience performing Batch Manufacturing and Packing, In-process checks/verifications in the Manufacturing and Packaging areas of TRANSDERMAL pharmaceuticals manufacturing environment.
• Experienced with operation & maintenance of pharmaceutical or any type of equipment/machinery.
• Certified in any engineering stream – preferred mechanical or instrumental engineering.
• experience with topical and inhalation product manufactruring is a plus

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• Medical and Rx Benefits choice of four medical plans through Client. Rx automatically provided with medical benefits
• Dental Benefits with three dental plan options through Client
• Vision Plan with two plan options through VSP
• Life Insurance, Basic Life and AD&D and Supplemental Life Insurance
• Disability Insurance, Voluntary Short-Term Disability and State Disability • Long-Term Disability (LTD), State (short term) disability – where applicable
• FSA (Flexible Spending Accounts) – Both Health Care & Dependent Care Available
• HSA (Health Savings Account)
• 401(k) Plan - Through Fidelity / Employer Match / fully vested after 3 years
• Employee Assistance Program (EAP) - 100% Confidential and 100% company paid
• Critical Illness and Accidental Insurance
• Legal and Identity Theft Insurance
• Paid Time Off - Paid vacation, PTO, Holiday

Notice to Recruitment Agencies:
Please note that we are not accepting unsolicited resumes or proposals from recruitment firms or agencies for this position. Thank you for your understanding.