דרושים Engineering Director ב-United States, Utah, Salt Lake City

This position is responsible for the oversight of the site Environmental, Health and Safety Program to ensure compliance with all federal and state EPA, OSHA and DOT regulations. This position oversees internal and external audits, risk analysis, hazard assessments, etc. This position also develops and implements programs to support safety culture.

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Responsible for ensuring compliance with federal and state regulatory requirements.
• Responsible for the facilitation of recognition, evaluation and control of environmental and occupational hazards.
• Responsible for ensuring compliance with all EH&S documentation such as OSHA 300 log, environmental permits, DOT shipping documents and training.
• Responsible for the oversight of internal environmental, health and safety audits to identify actual or potential hazards, institute corrective measures and follow up to ensure consistency.
• Respond to product safety requests for experimental & commercial materials including EH&S technology transfers, SDS’s, development and toxicity testing.
• Responsible for advising senior staff regarding current regulatory requirements and status, and pending legislation that may affect the business.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating
• Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• Requires an undergraduate degree or equivalent with a minimum of 10 year’s progressively relevant experience in a manufacturing environment.
• Requires understanding of federal and state requirements for environmental health and safety or related area(s) and controlled substances handling or related area(s).
• Requires knowledge of pharmaceutical manufacturing operations and lab procedures.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.
• Self-directed with ability to organize and prioritize work.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments, business units and external partners.
• Ability to demonstrate sound judgment and decision making.
• Ability to identify the developmental needs of others and provide coaching, mentoring and encouragement to help others improve their knowledge or skills.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to analyze information and create metrics relevant to the business objectives.
• Project management and advanced presentation skills preferred.

Problem Solving:

• Proactively works on problems of a complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to direct method and procedure for problem resolution.

Travel Requirements: Up to 10%

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Responsible for managing the sites production and materials planning, site product project management, and maintenance of site inventory control and policies.
• Responsible to work with Supply Chain Planning in preparation of Work in Process and budgets.
• Responsible for calculating labor and machine requirements at the Salt Lake City sites.
• Responsible for providing inventory leadership to support product transfers and avoid supply gaps; support new product launches.
• Responsible for managing supply relationships with Market Planners and outside suppliers. This responsibility includes investigation and recommendation of new and improved planning systems and processes, providing guidance to sites to focus and arrange schedules, add/subtract people, and buy equipment. Responsible to communicate this data and recommendations to senior management on a routine basis.
• Responsible to lead and innovate on the Sales and Operations Planning (S&OP) process. Present overall supply chain capacity status, raise significant capacity issues in S&OP and challenge capacity assumptions.
• Responsible to identify and evaluate critical positions within the function and establish strategies to develop a stronger talent pool. Select, coach, and develop talent and build a strong succession organization. Implement education and training for all participants in capacity planning processes. Ensure that demonstrated capacities are realistic; periodically attend plant meetings to assess and improve capacity planning performance.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires an undergraduate degree or equivalent with a minimum of 10 years’ relevant experience in a Manufacturing environment, Supply Chain or Materials Management.
• Requires strong knowledge of pharmaceutical materials and general manufacturing processes.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Experience with budget and project management tools is preferred.
• Specialized or Technical Knowledge Licenses, Certifications needed: SAP/APO, Oracle ERP, Microsoft Office Suite, APICS Certification is preferred.

Skills/Knowledge/Abilities:
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.
• Self-directed with ability to organize and prioritize work.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments, business units and external partners.
• Ability to demonstrate sound judgment and decision making.
• Ability to identify the developmental needs of others and provide coaching, mentoring and encouragement to help others improve their knowledge or skills.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to analyze information and create metrics relevant to the business objectives.
• Project management and advanced presentation skills preferred.

TRAVEL REQUIREMENTS: Up to 20%

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

This position will provide technical oversight of multiple pharmaceutical processes including OSD, capsules, transdermal patches, gels, creams, ointments, medical devices, and packaging. In addition, this position will manage: product launch, technology transfer, process development and optimization, commercial operations support/optimization, and organizational development.

• Responsible for management and development of direct and indirect reports.
• Responsible for providing oversight of the design and execution of experiments to optimize and scale-up commercial operations of new and current product products.
• Responsible for timely execution of product launch and technology transfer activities
• Responsible for all aspects of process validation and cleaning validation
• Responsible for supporting projects through the preparation and/or review of documents such as protocols, reports, master batch records, investigation reports, etc.
• Provide technical support for commercial products
• Provide significant contributions to product competitiveness via alternate material qualification and process/product optimization
• Responsible for building and maintaining departmental budget.
• Responsible for completing all training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires a BS, MS or PhD degree in a scientific or related discipline with a minimum of 8 years of progressively relevant experience in the pharmaceutical or related industry.
• Requires at least 4-5 years’ experience in process and cleaning validation, technical services or related functional areas.
• Requires experience with pharmaceutical manufacturing in a pharmaceutical environment for the global market.
• Requires working knowledge of basic statistical principles.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.

Skills/Knowledge/Abilities:
• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Veeva, Trackwise and Qdocs.
• Self-directed with ability to organize and prioritize work.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.
• Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
• Ability to build and maintain collaborative relationships between teams, departments, business units and external partners.
• Ability to demonstrate sound judgment and decision making.
• Ability to identify the developmental needs of others and provide coaching, mentoring and encouragement to help others improve their knowledge or skills.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to analyze information and create metrics relevant to the business objectives.
• Project management and advanced presentation skills preferred.

TRAVEL REQUIREMENTS: Up to 10%

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.