Senior Manufacturing Engineer

Position Summary

The Sr. Manufacturing Engineer is accountable for driving results in a fast-paced environment by supporting cGMP manufacturing.  The Sr. Manufacturing Engineer is responsible for troubleshooting unexpected manufacturing events; preparing, conducting and evaluating continued process verification activities; and providing on-going support of commercial and clinical manufacturing.  The Sr. Manufacturing Engineer works closely with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering to ensure robust production of cGMP Sterile Drug Products.  The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

·         Perform data analysis, including tracking and trending of manufacturing processes to identify areas of improvement.

·         Measure and evaluate unit operation durations to implement optimal scheduling to meet facility and client requirements.

·         Author protocols and reports needed to support investigations, process changes and equipment modifications.

·         Supports the creation and maintenance of cGMP production records and risk assessments.

·         Provides training to manufacturing staff on operating procedures, batch records and GMP process rationale.

·         Provides technical, on the floor support of commercial, clinical and validated processes.

·         Supports clients/stakeholders as a subject matter expert of commercial, clinical and generic products.

·         Evaluates product impact of process excursions outside proven acceptable ranges.

·         Seeks opportunities to improve process performance within process ranges defined by large-scale equipment capabilities.

·         Troubleshoots unexpected events during cGMP manufacturing, assists in investigating and documenting process deviations and CAPAs. 

·         Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.

·         Complies with all company and site policies and procedures.

·         Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

·         Ensures operations are performed in a safe, clean, and organized work environment free of safety hazards.

Education and Experience

·         Requires a Bachelor’s degree in Engineering, Chemical Engineering strongly preferred, with a minimum of 3 years of experience in the manufacture of sterile injectable products in a regulated environment.

Alcami Non-Negotiables

·         Consistently demonstrates honesty and integrity through personal example.

·         Follows all safety policies and leads by example a safety-first culture.

·         Produces high quality work product with a focus on first time right.

·         Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

·         Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.

·         Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.

·         Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.

·         Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.

·         Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.

·         Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

·         Ability to drive manufacturing operations and identify/improve inefficiencies

·         Ability to work with people at all levels of the organization.

·         Ability to create and interpret graphs and charts.

·         Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.

·         Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

·         Ability to write reports, business correspondence and procedure manuals.

·         Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations.

·         Ability to effectively present information and respond to questions from groups of managers and clients.

·         Basic knowledge of computers and Microsoft Office software products.

Decision Making and Supervision Required

·         Applies job skills, company policies and SOPs to complete a variety of tasks.

·         Receives general instructions on routine work, detailed instructions on new projects or assignments.

Travel Requirements

·         Up to 5% Travel required.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met by an employee 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 employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell.  The employee is frequently required to sit.  The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl.  The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  The noise level is moderate to noisy.  Occasionally, employee may be exposed to airborne particles and fumes or chemicals.  Must have the ability to wear PPE as required.  Employee occasionally may be exposed to moving mechanical parts and vibration.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.  Duties, responsibilities and activities may change at any time with or without notice.