175 Crossing Boulevard Suite 420
Job Category: Quality and Compliance
Job Number: 564823
Is job remote?: No
Country: United States
Pharma Systems Validation & Engineering Manager – (Full-time) – Hybrid – MA
Biotechnology organization just west of Boston seeks a full-time, hybrid Pharma Systems Validation and Engineering Manager. The ideal candidate will have 8+ years of field expertise within pharmaceutical validation and engineering and a minimum of 3+ years of management expertise within a GMP and FDA environment. Additionally, the ideal candidate will have hands-on experience having run, developed and troubleshot protein purification, clarification, UF/DF, TFF, and filtration processes and utilities for HVAC and water within a large-scale facility. Prior experience within biotech processes is required. Opportunity offers progressive growth within a stable organization that provides strong benefits and compensation within a hybrid work environment. Work/life balance is encouraged as is a “family first” focus.
- Competitive Base compensation.
- 5% annual Bonus Incentive based on company and personal performance.
- 15 Days’ Vacation accrued; after 5 years of employment this moves to 4 weeks; 10 years, 5 weeks.
- 8 days sick leave
- 13 days paid holidays.
- 2 days paid volunteer program.
- Competitive Health, Dental and Vision Insurance
- 401K with a 100% match for up to 6% full vested
- Fitness reimbursement program with company providing 50% up to $100 max monthly.
- Ability to work within an organization encouraging work/life balance and a “family first” focus.
- An open-door policy with Leadership
- Quarterly and annual recognition awards.
- Working with Senior Management to establish objectives and delegate assignments within pharmaceutical validation and engineering environment.
- Managing a team of 5, to include 1 direct report and several consultants, within GMP and FDA Environment.
- Implementing and maintaining quality systems and programs in support of all validation and engineering activities.
- Overseeing validation plan execution conducted by internal and external resources.
- Generating and maintaining Engineering and Validation Master Plans and other associated governing documentation.
- Developing engineering and validation requirements for equipment, facilities, utilities and GXP computer systems.
- Directing the completion of validation documentation prior to change implementation.
- Collaborating with various departments including Technical Operations, QC, IT, Supply Chain, GMP Systems and Manufacturing departments for validation planning and communication of standards and requirements.
- Serving as SME and POC for staff and regulatory inspections, by providing information and guidance regarding regulations and procedures, and as related to process equipment and computer system validation.
- Coaching and mentoring employes while ensuring performance feedback is provided.
- Modifying and executing company policies.
- Developing and administering schedules, performance requirements, policy implementation, methods, techniques, and more.
- Establishing and assuring adherence to budget, schedules, work plans and performance requirements.
- Managing all utilities systems in accordance with manufacturer’s recommendations and specifications, to include EHS and cGMP requirements.
- Working with Quality Department to ensure proper documentation, standards and practices are developed accordingly for new and existing systems and processes.
- Reviewing and approving SOPs, specifications, regulatory filings, and other controlled documentation to ensure regulatory and quality requirement adherence.
- BS degree or MS in Chemical, Process Engineering, Biological, Pharmaceutical Science, or associated areas.
- US Citizen/Green Card Holder.
- Covid Vaccination Required.
- Individual local to client site or willing to relocate near Boston.
- 8+ years pharmaceutical validation and engineering experience.
- 3+ years in management within a GMP and FDA environment.
- Prior hands-on experience running developing and troubleshooting protein purification, clarification, UF/DF, TFF, and filtration processes and utilities (HVAC and water) in large scale facility.
- Prior experience working within operations and upscaling biotech processes.
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