Technical Services Engineer

Primary Responsibility:

Technical Services Specialist is a key role to ensure flawless execution of all activities related to process development, manufacturing and supply of products. This includes (but is not limited to) leading technical transfers, completion of all annual product review reports, management of all commercial product deviations, complaints and investigations; training of the production team on new and recurring manufacturing batch processes; trouble-shooting production issues for both commercial and non-commercial scale-ups; assignment and completion of all production changeover walkthrough inspections; and technical leadership of several customer meetings, etc.

Duties and Responsibilities:

• Leading technical transfers between sites as a technical steward of products assigned
• Generation and review of process validation documents for commercial processes.
• Training of the production team on new and recurring commercial batch processes.
• Trouble-shooting production issues for both commercial and non-commercial scale-ups.
• Assignment and completion of all production changeover walkthrough inspections.
• Assignment and completion of all annual product review reports.
• Management of all commercial product deviations, complaints and investigations.
• Leadership of customer meetings to update status of a project or investigation and for routine communication
• Recommend and implement methods to increase the quality of products and/or services.
• Recommend and implement methods to decrease the internal cost of products and/or services.
• Plan and execute appropriate research techniques towards the solution of various chemical problems arising in the synthesis, analysis, development or production of chemical substances or drugs in the plant.
• Use a broad spectrum of practical laboratory skills as needed; including advanced methods of purification of solvents and reagents, running reactions under anhydrous and oxygen free conditions, and using advanced methods for isolation/purification of sensitive materials.
• Remain alert to the chemical literature especially in regard to recent developments vital to our processes and area of interest. Impart new chemical information and research techniques to junior chemical staff and manufacturing personnel.
• Communicate effectively in verbal and written form on research results, issues, and plans. Contribute suggestions to coworkers.
• Train and develop skills related to manipulation and analysis of organic chemicals in junior
• Perform preliminary hazard screening on new processes using appropriate methodology (DSC, TSU, and CRC90) to ensure safe pilot processes.
• Complete assignments pertaining to qualification/validation of equipment, processes and cleaning to support manufacturing facility.
• Typical assignments at this level would advance to include (but not limited to) temperature monitoring units, basic packaging equipment like printers, labelers, process development batches, and cleaning validation.
• Prepare equipment qualification, process validation and cleaning validation protocols including design of appropriate testing procedures and evaluation criteria.
• Perform execution of qualification and validation protocols.
• Prepare final report packages by analyzing results and preparing summaries of the data to support test and protocol requirements.
• Maintain a positive working relationship with peers and plant personnel to facilitate the completion of assignments.
• Communicate the status of project activities and possible issues that may impact the progress of projects to supervisor, project teams and other management, as needed.
• Prepare technical documentation to support regulatory filings and product launches such as batch records, process descriptions, etc., as needed.
• Prepare and update Standard Operating Procedures (SOPs) as needed.
• Assist the Technical Services Department in achieving the requirements of the approved Site Validation Master Plan and Validation Project Plans.
• Other duties as assigned to meet departmental and Company objectives.

Knowledge/Skills/Abilities

• Knowledge of and compliance with cGMP and other regulatory requirements such as NEC, OSHA, DEA and EPA.
• Demonstrated and applied knowledge of Six Sigma and Lean Manufacturing tools and methodologies strongly desired.
• Demonstrated success in technical proficiency, scientific creativity, collaboration with others, and independent thought to achieve stated goals.
• Excellent communication skills to effectively communicate in a clear, concise manner whether in oral, written or presentation form.
• Proven ability to effectively train, coach and mentor team members; influence and gain commitment at all organizational levels.
• Proven leadership skills in team formation, problem resolution and project execution follow up.
• Understanding of financial and other business measures to apply them effectively in the overall improvement process.
• Strong quantitative and analytical skills.
• PC proficiency using Microsoft Office required; Minitab and Visio desired.
• Demonstrated ability to work independently on complex problems and resolve technical issues.
• Flexible, with ability to handle and coordinate multiple projects in a dynamic, fast-paced environment.

Education/Experience

• Bachelor's degree in engineering, science, or related technical discipline.
• Minimum two years' experience in pharmaceutical industry or four years in other highly regulated industry.

Work environment

Described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point.
3. Must also have the ability to identify and distinguish colors.
4. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
5. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
6. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
7. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
8. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Current Openings for Technical Services Engineer Jobs at Nesher Pharmaceuticals (USA) LLC