Director of Engineering

Reagan Madison Solutions Inc. is partnering with a CDMO to hire a Director of Engineering, Validation, and Maintenance. Relocation assistance will be provided for this position.

Position Summary

The Director, Engineering, Validation and Maintenance drives results in a fast-paced environment by developing and executing engineering, validation, and maintenance strategies supporting on-going and future facility, utility, manufacturing and laboratory systems throughout the life cycle of an asset.

Engineering includes but is not limited to project scope, cost estimates, schedules, design, procurement, installation/construction, and plant engineering.

Validation includes factory acceptance tests, commissioning, installation qualification, operational qualification, performance qualification, and re-qualification program.

Maintenance includes but is not limited to preventative maintenance, work order repairs, and facilities programs including security, housekeeping, landscaping and pest control.

In addition, the Director, Engineering, Validation, and Maintenance supports the strategic development of the organizational capabilities of the department. The position requires superior leadership behaviors of the the Company’s core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Develops, implements, and maintains robust engineering, validation, metrology, and maintenance standards. Ensures changes are consistent with other sites in the network.
• Manages internal engineering, validation and maintenance processes as well as provides support to other groups. Including but not limited to:
• Capital Program: quarterly forecast, annual capital budget, long term capital plan, individual capital packages. Responsible for controlling the site’s capital budget and adhering to project schedules.
• Pest Control: bi-weekly third-party treatment/inspections, review/approval of third party results, annual program assessment, audit support
• Insurance Program Ownership: Property and Equipment Breakdown Surveys/audits. This includes back-up generators, roof inspections, fire protection amongst other like topics.
• Drawing Program: Review and approval of GMP critical, security drawings in EDMS and maintaining building and construction drawings
• Security Program: Includes badge readers, camera systems, intrusion systems, and oversight of security guards.
• Contractor Management: includes but not limited to training and escorting when applicable
• Facility and Utility Ownership: Must understand function, layout, and capacity of key site systems. Will be SME during client and regulatory audits on these topics.
• ESG: Will lead certain aspects of the site’s ESG program including understanding the amount of energy utilized at the sites and initiatives to reduce that usage. The team will be responsible for tracking what type of refrigerant is used in the site’s systems.
• Maintenance: will own the site’s preventative maintenance and work order programs (both GMP and non-GMP work orders)
• Business Continuity: will help spearhead the site’s Business Continuity Plans including water damage mitigation plans and key redundancies.
• Oversees the equipment, facilities and utilities qualification program, and drives innovation to remain current.
• Leads the site’s metrology group (calibrations and repairs).
• Leads the design, implementation, monitoring and control and closure stages of major department and capital projects for the facility.
• Leads and actively participates in client interface in regards to equipment, facility and utility lifecycle.
• Oversees and develops the facility long-term capital investment plan and departmental operating budget.
• Cultivates an efficient, professional and safe working atmosphere and ensures timely results are achieved.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Represents the department in meetings, collaborates and cooperates to achieve cross-functional improvements and business goals
• Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer
• Manages the day-to-day operations for assigned area.
• Participates in and supports client visits, audits and inquiries to ensure complete fulfillment of requests and interests.
• Provides technical guidance for troubleshooting and investigating simple to complex issues in area of expertise.
• Effectively resolves quality issues and concerns in a timely manner.
• Actively contributes to the preparation and coordination of internal audits and regulatory inspections.
• Creates strong and effective relationships with clients.
• Maintains a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses.
• Other duties as assigned.

Education and Experience

• Bachelor’s degree in Engineering, Chemical, Mechanical, Biochemical, or equivalent required.
• 10 years of related experience required;
• Prior pharmaceutical experience required; prior CDMO experience preferred.

Knowledge

• Strong technical skills for area managing
• Good business acumen
• Strong understanding of company SOPs, and regulatory guidance documents.
• Strong knowledge of safety procedures and quality compliance for assigned area
• Strong knowledge of cGMP requirements.
• Experience with client audits.
• Strong understanding of basic lab techniques.
• Strong knowledge of FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
• If applicable, experience with compliance for API and drug product and/or drug substance.
• Experience with regulatory agency inspections of GXP facilities.
• Experience working with CDMOs.

Skills / Abilities:

• Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites.
• Excellent analytical and problem-solving skills, with the ability to think strategically.
• Strong attention to detail, as well as time and resource management.
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
• Promote a safe environment for work.
• Comply with the general policy of the company.
• High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
• Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.
• Communicate well orally both for
• Internal customers and team members
• External customers
• Ability to write reports and business correspondence.
• Ability to listen and respond well to external customers, partners and colleagues at all levels.
• Highly goal and result oriented.
• Prioritize tasks according to business objectives and can pursue several objectives simultaneously.
• Works independently with a high degree of self-motivation.
• Knows how to obtain support from different collaborations.
• Tackles problems with enthusiasm and curiosity.
• Treats colleagues at all levels with respect.
• Very effective listening skills with the ability to hear attentively and process information correctly.

Supervision Received: General

Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.

Functional Competencies

• Expert knowledge in cGMP, engineering standards, methodologies and maintenance, project engineering, and validation lifecycle required.
• Knowledge of quality systems preferred.
• Excellent verbal and written communication and presentation skills.
• Strong time and project management skills.
• Detail oriented with strong organizational skills.
• Strong business acumen required.
• Excellent experience with customer interface and preferred cross-functional and international business experience preferred.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Ability to perform complex math functions, compute ratios, rates, and percentages.
• Ability to draw and interpret graphs and charts.
• Proficient in Microsoft Office applications.