Responsible for providing cGMP compliant manufacturing capacity and facilities for current and future needs for production, laboratory, and office functions, through directing and managing, developing and structuring all aspects of Engineering, including Packaging for the Irvine site. Monitors work for compliance to applicable codes, accepted engineering practices, company standards and policies.
Supervises a staff of Managers and Engineers assigned to manage and lead projects within the TPM site.
Prioritizes and guides engineering resources in the design of new or improvement / expansion of existing manufacturing processes to deliver FDA compliant production capacity on time and within budget according to business plan
Ensures the completion of projects and activities within established time frames required to meet company objectives. Department is also responsible for facility’s change control process.
Staff is responsible for development of label, package, and shipper specifications for all Teva and contract customer products.
Plans and manages capital plan for facility and production equipment related spending to assure production is in a position to meet new product development, product launch, and contract manufacturing requirements.
Guides the specification and selection of manufacturing equipment/utility equipment and rewards architectural and engineering contracts based on comparative bids and analysis developed by site Project Managers.
Provides adequate workspace for all functions on-site through space planning for offices, laboratories and manufacturing areas.
Adapts engineering organization to meet changing product portfolio and customer demands through appropriate hiring and organizational structuring.
Participates as a member in various steering committees to guide and influence the company’s focus on new products, new customers, and strategic initiatives.
Works with engineering design firms and general contractors.
Oversees engineering project management for cGMP facilities. Provides guidance, leadership, and mentorship to staff in areas of Engineering, project management and professional development. Holds individuals accountable for the work performed, meeting timelines and budgets.
Communicates significant equipment or process issues to site leadership.
Prepare monthly reports to Company management detailing the status of open projects that support the capacity, regulatory and process improvement requirements of the plant.
Oversees the career and leadership development of the department Managers and engineers. Ensure effective communication, planning and coordination between other functions.
Keeps abreast of technological developments relating to engineering and project management in commercial pharmaceutical manufacturing facilities.
Creative approach to problem solving, policy making and to leading the engineering team in order to support the existing manufacturing operations and future capacity needs while working closely with senior management colleagues in a team environment.
Work is largely self-assigned through development and update of the capital plan, which receives input from all departments. The Capital plan is then translated into the engineering resource plan and projects are scoped, scheduled, and assigned to the engineers through interaction with the departmental engineering managers.
Beginning of year goal-schedule aligns all significant goals and objectives, quarterly goal updates are given to the organization, and monthly reports inform superior of progress, status and issues.
Lead a diverse staff of technical professionals to achieve broad goals defined by Company management. Develops long range facility plans with a focus on quality and productivity improvement. Provides the leadership necessary to implement those plans while responding to immediate, short-term facility needs.
Assure that engineering projects are effectively managed to provide a high likelihood of achieving project quality, scope, schedule and budget objectives.
Maintain a high degree of visibility and awareness within the professional community.
Periodic travel for equipment evaluation, trade shows, and possible overseas travel.
Bachelors degree in an engineering or scientific discipline. Mechanical, Chemical or Controls Engineering degree (B.S.)
Mechanical, Civil, Chemical or Controls Engineering degree is desirable. Qualification in engineering management through MBA or M.S. degree or equivalent combination of education, training and experience is required.
At least ten years experience, with a minimum of five years in a senior supervisory role, and 7 years sterile pharmaceutical manufacturing experience (preferably with Small Volume Parenterals-SVP’s).
Masters Degree in an engineering, scientific or business administrative discipline and at least seven years experience, with a minimum of three to five years in a senior supervisory role; or equivalent combination of education, training and experience preferred
Significant experience in the pharmaceutical industry in a cGMP environment is a requirement for this position. Pharmaceutical experience should include roles in engineering, project and general management. Experienced in building and managing effective teams. Previous experience in management of multiple large capital projects is needed. SVP manufacturing process design experience is also needed. Environmental protection, safety engineering, and security knowledge.
Member, ISPE (International Society of Pharmaceutical Engineers) and PDA (Parenteral Drug Association)
Excellent communication skills - writing and verbal
Sterile facility and equipment design and construction/fabrication.
Capital Plan / Asset Management.
CGMP knowledge for vial, ampoule, syringe and flexible bag manufacturing.
Automation and machine controls basics.
Quality Management / Six Sigma Principles / Balanced Score Card Principles.
Contract Manufacturing Principles
Professional Engineering Registration is desired but not required.
FDA Regulations: cGMPs as in 21 CFR, part 11, 210, 211), Federal Standard 209E (now ISO 14644, 14698) and Aseptic Manufacturing Guideline. EU (EMEA/MCA) Regulations: European GMP, Annex 1 on Manufacture of Sterile Medicinal Products,
Project engineering management procedures and principles.
Capital plan/ budget control/ asset management/planning/ management policies.
Sterile pharmaceutical engineering practices and guidelines as in GAMP 4 and ISPE baseline guide Pharmaceutical Engineering, Volume 1 through 4.
UCC Contract Law as it relates to purchasing, A&E and Construction work.
Working knowledge of Environmental Health, Industrial Hygiene and Workplace Safety (OSHA) regulations and containment of hazardous and potent compound handling.
Ability to understand and execute instructions provided in English, verbal or written.
Ability to clearly document information for recordkeeping purposes.
Accuracy in data/record entry (MS Excel, MS Access)
Demonstrates an attention to detail
Understands importance of timely completion of filing and indexing.
Ability to work with people.
Ability to effectively manage people, set clear expectations and provide situational leadership.
Ability to work independently and on teams.
As a member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business.
Teva Parenteral Medicines offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company.
When the pharmacist asks you if a generic equivalent is acceptable, Teva hopes you'll say "yes." Teva Pharmaceuticals USA,...